Microbiology Device Classification Codes

JWY Class 2

Manual Antimicrobial Susceptibility Test Systems

Clearances 426

Regulation 21 CFR 866.1640

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JTN Class 2

Susceptibility Test Discs, Antimicrobial

Clearances 328

Regulation 21 CFR 866.1620

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JSJ Class 1

Culture Media, Selective And Non-Differential

Clearances 307

Regulation 21 CFR 866.2360

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JSI Class 1

Culture Media, Selective And Differential

Clearances 285

Regulation 21 CFR 866.2360

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LON Class 2

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Clearances 285

Regulation 21 CFR 866.1645

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JTO Class 1

Discs, Strips And Reagents, Microorganism Differentiation

Clearances 244

Regulation 21 CFR 866.2660

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JSG Class 1

Culture Media, Non-Selective And Non-Differential

Clearances 209

Regulation 21 CFR 866.2300

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JSH Class 1

Culture Media, Non-Selective And Differential

Clearances 146

Regulation 21 CFR 866.2320

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LSR Class 2

Reagent, Borrelia Serological Reagent

Clearances 111

Regulation 21 CFR 866.3830

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JSM Class 1

Culture Media, Non-Propagating Transport

Clearances 107

Regulation 21 CFR 866.2390

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GTZ Class 1

Antisera, All Groups, Streptococcus Spp.

Clearances 105

Regulation 21 CFR 866.3740

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LGD Class 2

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Clearances 105

Regulation 21 CFR 866.3780

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LFX Class 2

Enzyme Linked Immunoabsorbent Assay, Rubella

Clearances 94

Regulation 21 CFR 866.3510

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LYR Class 1

Helicobacter Pylori

Clearances 89

Regulation 21 CFR 866.3110

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JSF Class 1

Culture Media, Single Biochemical Test

Clearances 87

Regulation 21 CFR 866.2320

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JTY Class 2

Culture Media, For Isolation Of Pathogenic Neisseria

Clearances 83

Regulation 21 CFR 866.2410

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JTZ Class 2

Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Clearances 74

Regulation 21 CFR 866.1700

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JSK Class 1

Supplement, Culture Media

Clearances 70

Regulation 21 CFR 866.2450

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GRM Class 2

Antisera, All Groups, Salmonella Spp.

Clearances 69

Regulation 21 CFR 866.3550

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PSZ Class 2

Devices Detecting Influenza A, B, And C Virus Antigens

Clearances 68

Regulation 21 CFR 866.3328

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LJC Class 1

Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

Clearances 67

Regulation 21 CFR 866.3120

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MDB Class 1

System, Blood Culturing

Clearances 67

Regulation 21 CFR 866.2560

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OCC Class 2

Respiratory Virus Panel Nucleic Acid Assay System

Clearances 67

Regulation 21 CFR 866.3980

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JTC Class 1

Device, Microtiter Diluting/Dispensing

Clearances 66

Regulation 21 CFR 866.2500

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LIO Class 1

Device, Specimen Collection

Clearances 63

Regulation 21 CFR 866.2900

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GNC Class 2

Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

Clearances 60

Regulation 21 CFR 866.3550

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LFZ Class 2

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Clearances 56

Regulation 21 CFR 866.3175

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LSE Class 1

Epstein-Barr Virus, Other

Clearances 56

Regulation 21 CFR 866.3235

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JSE Class 1

Culture Media, Multiple Biochemical Test

Clearances 53

Regulation 21 CFR 866.2320

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JSC Class 1

Culture Media, General Nutrient Broth

Clearances 52

Regulation 21 CFR 866.2350

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KZI Class 1

Culture Media, Enriched

Clearances 51

Regulation 21 CFR 866.2330

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LTT Class 2

Panels, Test, Susceptibility, Antimicrobial

Clearances 49

Regulation 21 CFR 866.1640

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JSS Class 1

Kit, Identification, Enterobacteriaceae

Clearances 48

Regulation 21 CFR 866.2660

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LRG Class 2

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Clearances 45

Regulation 21 CFR 866.1640

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JXA Class 1

Kit, Screening, Urine

Clearances 44

Regulation 21 CFR 866.2660

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JTW Class 1

System, Transport, Aerobic

Clearances 43

Regulation 21 CFR 866.2900

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LIB Class 1

Device, General Purpose, Microbiology, Diagnostic

Clearances 43

Regulation 21 CFR 866.2660

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GTY Class 1

Antigens, All Groups, Streptococcus Spp.

Clearances 42

Regulation 21 CFR 866.3740

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LLH Class 1

Reagents, Clostridium Difficile Toxin

Clearances 42

Regulation 21 CFR 866.2660

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LSL Class 2

Dna-Reagents, Neisseria

Clearances 42

Regulation 21 CFR 866.3390

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GNB Class 2

Antisera, All Types, Shigella Spp.

Clearances 41

Regulation 21 CFR 866.3660

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JSO Class 2

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Clearances 40

Regulation 21 CFR 866.1700

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LGC Class 2

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Clearances 38

Regulation 21 CFR 866.3305

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GQL Class 2

Antisera, Fluorescent, Herpesvirus Hominis 1,2

Clearances 37

Regulation 21 CFR 866.3305

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GTQ Class 1

Antistreptolysin - Titer/Streptolysin O Reagent

Clearances 37

Regulation 21 CFR 866.3720

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LIP Class 2

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

Clearances 35

Regulation 21 CFR 866.3830

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LJP Class 1

Antiserum, Fluorescent, Chlamydia Trachomatis

Clearances 35

Regulation 21 CFR 866.3120

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QOF Class 2

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Clearances 35

Regulation 21 CFR 866.3981

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GQN Class 2

Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

Clearances 34

Regulation 21 CFR 866.3305

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LIQ Class 1

Enzyme Linked Immunoabsorbent Assay, Rotavirus

Clearances 33

Regulation 21 CFR 866.3405

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GQG Class 1

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Clearances 32

Regulation 21 CFR 866.3480

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GMQ Class 2

Antigens, Nontreponemal, All

Clearances 31

Regulation 21 CFR 866.3820

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PMN Class 2

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Clearances 31

Regulation 21 CFR 866.3920

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PCH Class 2

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Clearances 29

Regulation 21 CFR 866.3990

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LJG Class 1

Quality Control Slides

Clearances 27

Regulation 21 CFR 866.2660

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LLM Class 1

Test, Antigen, Nuclear, Epstein-Barr Virus

Clearances 27

Regulation 21 CFR 866.3235

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MHI Class 2

Giardia Spp.

Clearances 27

Regulation 21 CFR 866.3220

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JSD Class 1

Culture Media, Selective Broth

Clearances 26

Regulation 21 CFR 866.2360

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LOL Class 2

Hepatitis A Test (Antibody And Igm Antibody)

Clearances 24

Regulation 21 CFR 866.3310

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LJN Class 1

Antibody Igm, If, Epstein-Barr Virus

Clearances 23

Regulation 21 CFR 866.3235

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LKT Class 1

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

Clearances 23

Regulation 21 CFR 866.3480

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NQX Class 2

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Clearances 23

Regulation 21 CFR 866.1640

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QEP Class 2

Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

Clearances 23

Regulation 21 CFR 866.3393

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GOL Class 2

Antigen, Ha (Including Ha Control), Rubella

Clearances 21

Regulation 21 CFR 866.3510

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GNP Class 1

Antiserum, Cf, Epstein-Barr Virus

Clearances 20

Regulation 21 CFR 866.3235

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JWX Class 1

Kit, Screening, Staphylococcus Aureus

Clearances 20

Regulation 21 CFR 866.2660

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GQH Class 2

Antigen, Cf (Including Cf Control), Cytomegalovirus

Clearances 19

Regulation 21 CFR 866.3175

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GLZ Class 2

Antigens, If, Toxoplasma Gondii

Clearances 18

Regulation 21 CFR 866.3780

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GNX Class 1

Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

Clearances 18

Regulation 21 CFR 866.3330

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GQI Class 2

Antiserum, Cf, Cytomegalovirus

Clearances 18

Regulation 21 CFR 866.3175

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JSP Class 1

Kit, Anaerobic Identification

Clearances 18

Regulation 21 CFR 866.2660

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KHW Class 2

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Clearances 18

Regulation 21 CFR 866.3220

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KZJ Class 1

Device, Gas Generating

Clearances 18

Regulation 21 CFR 866.2580

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LHL Class 2

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

Clearances 18

Regulation 21 CFR 866.3300

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LKQ Class 2

Antibody Igm,If, Cytomegalovirus Virus

Clearances 18

Regulation 21 CFR 866.3175

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MKZ Class 1

Dna Probe, Nucleic Acid Amplification, Chlamydia

Clearances 18

Regulation 21 CFR 866.3120

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MXJ Class 2

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Clearances 18

Regulation 21 CFR 866.3305

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NGZ Class 2

Susceptibility Test Plate, Antifungal

Clearances 18

Regulation 21 CFR 866.1640

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LIN Class 2

Antisera, Conjugated Fluorescent, Cytomegalovirus

Clearances 17

Regulation 21 CFR 866.3175

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MSQ Class 1

Test, Urea (Breath Or Blood)

Clearances 17

Regulation 21 CFR 866.3110

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NJR Class 1

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Clearances 17

Regulation 21 CFR 866.3740

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GNW Class 1

Antisera, Cf, Influenza Virus A, B, C

Clearances 16

Regulation 21 CFR 866.3330

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GQO Class 2

Antisera, Cf, Herpesvirus Hominis 1,2

Clearances 16

Regulation 21 CFR 866.3305

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GTJ Class 2

Antisera, All Groups, N. Meningitidis

Clearances 16

Regulation 21 CFR 866.3390

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JSX Class 1

Kit, Identification, Neisseria Gonorrhoeae

Clearances 16

Regulation 21 CFR 866.2660

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JXB Class 1

Kit, Identification, Yeast

Clearances 16

Regulation 21 CFR 866.2660

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LFY Class 2

Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

Clearances 16

Regulation 21 CFR 866.3900

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LTW Class 2

Susceptibility Test Cards, Antimicrobial

Clearances 16

Regulation 21 CFR 866.1640

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OZE Class 2

Influenza A And Influenza B Multiplex Nucleic Acid Assay

Clearances 16

Regulation 21 CFR 866.3980

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OZN Class 2

C. Difficile Toxin Gene Amplification Assay

Clearances 16

Regulation 21 CFR 866.3130

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QBD Class 2

Microbial Nucleic Acid Storage And Stabilization Device

Clearances 16

Regulation 21 CFR 866.2950

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LQF Class 1

Dna-Reagents, Mycobacterium Spp.

Clearances 15

Regulation 21 CFR 866.3370

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MHJ Class 2

Cryptosporidium Spp.

Clearances 15

Regulation 21 CFR 866.3220

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GMZ Class 1

Antigens, All Types, Escherichia Coli

Clearances 14

Regulation 21 CFR 866.3255

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JTT Class 2

Susceptibility Test Powders, Antimicrobial

Clearances 14

Regulation 21 CFR 866.1640

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QYT Class 2

Over-The-Counter Covid-19 Antigen Test

Clearances 14

Regulation 21 CFR 866.3984

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JSN Class 1

Culture Media, Propagating Transport

Clearances 13

Regulation 21 CFR 866.2390

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LHT Class 1

Staphylococcus Aureus Somatic Antigens

Clearances 13

Regulation 21 CFR 866.3700

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LJZ Class 1

Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Clearances 13

Regulation 21 CFR 866.3375

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LKS Class 1

Device, Parasite Concentration

Clearances 13

Regulation 21 CFR 866.2900

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LQN Class 2

Latex Agglutination Assay, Rubella

Clearances 13

Regulation 21 CFR 866.3510

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GMJ Class 2

Antigens, Histoplasma Capsulatum, All

Clearances 12

Regulation 21 CFR 866.3320

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GNA Class 1

Antisera, All Types, Escherichia Coli

Clearances 12

Regulation 21 CFR 866.3255

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GSO Class 2

Antigens (Febrile), Agglutination, Brucella Spp.

Clearances 12

Regulation 21 CFR 866.3085

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JTL Class 1

Plasma, Coagulase, Human, Horse And Rabbit

Clearances 12

Regulation 21 CFR 866.2160

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JTQ Class 1

Bath, Incubators/Water, All

Clearances 12

Regulation 21 CFR 866.2540

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JTR Class 1

Kit, Quality Control For Culture Media

Clearances 12

Regulation 21 CFR 866.2480

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LJO Class 2

Antigen, Iha, Cytomegalovirus

Clearances 12

Regulation 21 CFR 866.3175

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LQP Class 1

Campylobacter Spp.

Clearances 12

Regulation 21 CFR 866.3110

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GMI Class 2

Antigen, Cf And / Or Id, Coccidioides Immitis

Clearances 11

Regulation 21 CFR 866.3135

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GOD Class 1

Antigens, Cf (Including Cf Control), Adenovirus 1-33

Clearances 11

Regulation 21 CFR 866.3020

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GOK Class 2

Antisera, Hai (Including Hai Control), Rubella

Clearances 11

Regulation 21 CFR 866.3510

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GQS Class 1

Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4

Clearances 11

Regulation 21 CFR 866.3400

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GQX Class 2

Antiserum, Cf, Varicella-Zoster

Clearances 11

Regulation 21 CFR 866.3900

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JTA Class 1

Monitor, Microbial Growth

Clearances 11

Regulation 21 CFR 866.2560

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JWZ Class 1

Kit, Screening, Trichomonas

Clearances 11

Regulation 21 CFR 866.2660

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LJB Class 1

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

Clearances 11

Regulation 21 CFR 866.3520

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LQL Class 1

Gram Positive Identification Panel

Clearances 11

Regulation 21 CFR 866.2660

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PQA Class 2

Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Clearances 11

Regulation 21 CFR 866.3975

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QQX Class 2

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Clearances 11

Regulation 21 CFR 866.3981

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SCA Class 2

Multi-Analyte Respiratory Virus Antigen Detection Test

Clearances 11

Regulation 21 CFR 866.3987

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GMD Class 2

Antisera, Latex Agglutination, Cryptococcus Neoformans

Clearances 10

Regulation 21 CFR 866.3165

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GQW Class 2

Antigen, Cf, (Including Cf Control), Varicella-Zoster

Clearances 10

Regulation 21 CFR 866.3900

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MCB Class 1

Antigen, C. Difficile

Clearances 10

Regulation 21 CFR 866.2660

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MJH Class 2

Legionella, Spp., Elisa

Clearances 10

Regulation 21 CFR 866.3300

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MYF Class 2

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

Clearances 10

Regulation 21 CFR 866.3305

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OQW Class 2

2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

Clearances 10

Regulation 21 CFR 866.3332

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PEN Class 2

Gram-Negative Bacteria And Associated Resistance Markers

Clearances 10

Regulation 21 CFR 866.3365

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GMK Class 2

Antiserum, Positive Control, Histoplasma Capsulatum

Clearances 9

Regulation 21 CFR 866.3320

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GMP Class 2

Antisera, Control For Nontreponemal Tests

Clearances 9

Regulation 21 CFR 866.3820

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GMT Class 2

Antigens, Ha, Treponema Pallidum

Clearances 9

Regulation 21 CFR 866.3830

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GNM Class 1

Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

Clearances 9

Regulation 21 CFR 866.3145

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GNS Class 1

Antisera, Hai, Influenza Virus A, B, C

Clearances 9

Regulation 21 CFR 866.3330

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GWC Class 1

Antisera, All Types, Streptococcus Pneumoniae

Clearances 9

Regulation 21 CFR 866.3740

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JRY Class 1

Antiserum, Fluorescent, Epstein-Barr Virus

Clearances 9

Regulation 21 CFR 866.3235

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LIC Class 2

Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae

Clearances 9

Regulation 21 CFR 866.3390

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NOP Class 2

Elisa, Antibody, West Nile Virus

Clearances 9

Regulation 21 CFR 866.3940

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PGX Class 2

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Clearances 9

Regulation 21 CFR 866.2680

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QVF Class 2

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Clearances 9

Regulation 21 CFR 866.3982

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GMM Class 2

Antigens, Iha, Toxoplasma Gondii

Clearances 8

Regulation 21 CFR 866.3780

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JSA Class 1

Culture Media, Antibiotic Assay

Clearances 8

Regulation 21 CFR 866.2350

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JSL Class 1

Culture Media, Anaerobic Transport

Clearances 8

Regulation 21 CFR 866.2390

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JTX Class 1

Transport Systems, Anaerobic

Clearances 8

Regulation 21 CFR 866.2900

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LJY Class 1

Enzyme Linked Immunoabsorbent Assay, Mumps Virus

Clearances 8

Regulation 21 CFR 866.3380

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LKH Class 1

Antisera, Immunoperoxidase, Chlamydia Spp.

Clearances 8

Regulation 21 CFR 866.3120

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LSK Class 1

Dna-Reagents, Chlamydia

Clearances 8

Regulation 21 CFR 866.3120

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MCD Class 1

Antigen, Ebv, Capsid

Clearances 8

Regulation 21 CFR 866.3235

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MYI Class 2

System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Clearances 8

Regulation 21 CFR 866.1640

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PRI Class 2

Procalcitonin Assay

Clearances 8

Regulation 21 CFR 866.3215

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SAN Class 2

Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

Clearances 8

Regulation 21 CFR 866.1650

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GOE Class 1

Antisera, Fluorescent, Poliovirus 1-3

Clearances 7

Regulation 21 CFR 866.3405

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LIE Class 2

Reagent/Device, Inoculum Calibration

Clearances 7

Regulation 21 CFR 866.1640

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LQM Class 1

Gram Negative Identification Panel

Clearances 7

Regulation 21 CFR 866.2660

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LSC Class 1

Neisseria Controls

Clearances 7

Regulation 21 CFR 866.2660

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LYF Class 2

Pneumocystis Carinii

Clearances 7

Regulation 21 CFR 866.3780

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GRP Class 2

Antisera, All Types, H. Influenza

Clearances 6

Regulation 21 CFR 866.3300

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GSA Class 1

Antisera, All Mycoplasma Spp.

Clearances 6

Regulation 21 CFR 866.3375

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JST Class 1

Kit, Fastidious Organisms

Clearances 6

Regulation 21 CFR 866.2660

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JSW Class 1

Kit, Identification, Glucose Nonfermenter

Clearances 6

Regulation 21 CFR 866.2660

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JXC Class 1

Kit, Screening, Yeast

Clearances 6

Regulation 21 CFR 866.2660

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LJK Class 2

Antisera, If, Toxoplasma Gondii

Clearances 6

Regulation 21 CFR 866.3780

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LKI Class 1

Antisera, Fluorescent, Chlamydia Spp.

Clearances 6

Regulation 21 CFR 866.3120

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MIU Class 1

Enzyme Linked Immunosorbent Assay, T. Cruzi

Clearances 6

Regulation 21 CFR 866.3870

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NIJ Class 2

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Clearances 6

Regulation 21 CFR 866.1640

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OEM Class 2

Human Metapneumovirus (Hmpv) Rna Assay System

Clearances 6

Regulation 21 CFR 866.3980

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OQO Class 2

Herpes Simplex Virus Nucleic Acid Amplification Assay

Clearances 6

Regulation 21 CFR 866.3305

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OZZ Class 2

Bordetella Pertussis Dna Assay System

Clearances 6

Regulation 21 CFR 866.3980

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PAM Class 2

Gram-Positive Bacteria And Their Resistance Markers

Clearances 6

Regulation 21 CFR 866.3365

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PGI Class 2

Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Clearances 6

Regulation 21 CFR 866.3309

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GMG Class 2

Antigen, Latex Agglutination, Coccidioides Immitis

Clearances 5

Regulation 21 CFR 866.3135

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GMH Class 2

Antiserum, Positive Control, Coccidioides Immitis

Clearances 5

Regulation 21 CFR 866.3135

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GNT Class 1

Antigens, Ha (Including Ha Control), Influenza Virus A, B, C

Clearances 5

Regulation 21 CFR 866.3330

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GON Class 2

Antigen, Cf (Including Cf Control), Rubella

Clearances 5

Regulation 21 CFR 866.3510

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GRZ Class 1

Antisera, Fluorescent, All, Mycoplasma Spp.

Clearances 5

Regulation 21 CFR 866.3375

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GSB Class 1

Antigens, Cf, All, Mycoplasma Spp.

Clearances 5

Regulation 21 CFR 866.3375

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JSY Class 1

Kit, Identification, Mycobacteria

Clearances 5

Regulation 21 CFR 866.2660

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JWT Class 1

Antigen, Cf, Aspergillus Spp.

Clearances 5

Regulation 21 CFR 866.3040

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KFG Class 1

Antiserum, Positive Control, Aspergillus Spp.

Clearances 5

Regulation 21 CFR 866.3040

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LKA Class 2

Culture Media, Antimicrobial Susceptibility Test

Clearances 5

Regulation 21 CFR 866.1700

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MJA Class 2

Susceptibility Test Powders, Antimycobacterial

Clearances 5

Regulation 21 CFR 866.1640

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NHT Class 2

Assay, Nucleic Acid Amplification, Bacillus Anthracis

Clearances 5

Regulation 21 CFR 866.3045

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GNY Class 1

Antisera, Fluorescent, Adenovirus 1-33

Clearances 4

Regulation 21 CFR 866.3020

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GPW Class 1

Antigen, Cf, Psittacosis (Chlamydia Group)

Clearances 4

Regulation 21 CFR 866.3120

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GQT Class 1

Antisera, Cf, Parainfluenza Virus 1-4

Clearances 4

Regulation 21 CFR 866.3400

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GRE Class 1

Antiserum, Fluorescent, Rubeola

Clearances 4

Regulation 21 CFR 866.3520

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GRO Class 2

Antisera, Fluorescent, All Types, Hemophilus Spp.

Clearances 4

Regulation 21 CFR 866.3300

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GSM Class 2

Antisera, Fluorescent, Brucella Spp.

Clearances 4

Regulation 21 CFR 866.3085

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GTN Class 1

Antisera, Fluorescent, All Types, Staphylococcus Spp.

Clearances 4

Regulation 21 CFR 866.3700

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JWL Class 2

Antigen, Treponema Pallidum For Fta-Abs Test

Clearances 4

Regulation 21 CFR 866.3830

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KFH Class 2

Antiserum, Positive Control, Blastomyces Dermatitidis

Clearances 4

Regulation 21 CFR 866.3060

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LHK Class 2

Antigen, Id, Candida Albicans

Clearances 4

Regulation 21 CFR 866.3165

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LHW Class 1

Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment

Clearances 4

Regulation 21 CFR 866.3720

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LJF Class 1

Device, Antimicrobial Drug Removal

Clearances 4

Regulation 21 CFR 866.2560

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LLA Class 2

Direct Agglutination Test, Toxoplasma Gondii

Clearances 4

Regulation 21 CFR 866.3780

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LQO Class 1

Dna-Reagents, Campylobacter Spp.

Clearances 4

Regulation 21 CFR 866.3110

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LRH Class 1

Instrument For Auto Reader Of Overnight Microorganism Identification System

Clearances 4

Regulation 21 CFR 866.2660

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LSQ Class 1

Reagent, Rickettsia Serological

Clearances 4

Regulation 21 CFR 866.3500

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MDK Class 1

Dna-Probe, Reagents, Streptococcal

Clearances 4

Regulation 21 CFR 866.3740

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MZP Class 2

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Clearances 4

Regulation 21 CFR 866.3170

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NOM Class 1

Antigen, Galactomannan, Aspergillus Spp.

Clearances 4

Regulation 21 CFR 866.3040

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NXX Class 1

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus

Clearances 4

Regulation 21 CFR 866.3700

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OAH Class 1

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

Clearances 4

Regulation 21 CFR 866.3740

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OMG Class 2

Antisera, Fluorescent, Human Metapneumovirus

Clearances 4

Regulation 21 CFR 866.3980

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OMN Class 1

C. Difficile Nucleic Acid Amplification Test Assay

Clearances 4

Regulation 21 CFR 866.2660

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PBK Class 2

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Clearances 4

Regulation 21 CFR 866.3315

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PCI Class 2

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Clearances 4

Regulation 21 CFR 866.3990

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PMT Class 2

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Clearances 4

Regulation 21 CFR 866.3215

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POC Class 2

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

Clearances 4

Regulation 21 CFR 866.1640

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PQZ Class 1

Gbs Culture Media, Selective And Differential

Clearances 4

Regulation 21 CFR 866.2360

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PRE Class 2

Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

Clearances 4

Regulation 21 CFR 866.3215

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PTF Class 2

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Clearances 4

Regulation 21 CFR 866.3215

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QPS Class 2

Immunoassay For Host Biomarkers Of Infection

Clearances 4

Regulation 21 CFR 866.3215

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QQV Class 2

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Clearances 4

Regulation 21 CFR 866.3378

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SEI Class 2

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

Clearances 4

Regulation 21 CFR 866.3173

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GMN Class 2

Antigens, Cf, Toxoplasma Gondii

Clearances 3

Regulation 21 CFR 866.3780

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GMS Class 2

Anti-Human Globulin, Fta-Abs Test

Clearances 3

Regulation 21 CFR 866.3830

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GNK Class 1

Antisera, Cf, Echovirus 1-34

Clearances 3

Regulation 21 CFR 866.3205

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GOG Class 1

Antisera, Cf, Poliovirus 1-3

Clearances 3

Regulation 21 CFR 866.3405

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GQM Class 2

Antisera, Neutralization, Herpesvirus Hominis

Clearances 3

Regulation 21 CFR 866.3305

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GRA Class 1

Antiserum, Fluorescent, Mumps Virus

Clearances 3

Regulation 21 CFR 866.3380

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GRC Class 1

Antigen, Cf (Including Cf Control), Mumps Virus

Clearances 3

Regulation 21 CFR 866.3380

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GSN Class 2

Antiserum, Positive And Negative Febrile Antigen Control Serum

Clearances 3

Regulation 21 CFR 866.3085

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GSQ Class 2

Antiserum, Vibrio Cholerae, All Varieties

Clearances 3

Regulation 21 CFR 866.3930

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GSZ Class 1

Antigens, Febrile (Weil-Felix), All Groups

Clearances 3

Regulation 21 CFR 866.3410

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GTH Class 2

Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae

Clearances 3

Regulation 21 CFR 866.3390

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GTP Class 1

Exoenzymes, Multiple, Streptococcal

Clearances 3

Regulation 21 CFR 866.3720

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JWW Class 2

Antigen, Cf, B. Dermatitidis

Clearances 3

Regulation 21 CFR 866.3060

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KZK Class 1

Reader, Zone, Automated

Clearances 3

Regulation 21 CFR 866.2850

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LHJ Class 1

Staphylococcus Aureus Protein A Insoluble

Clearances 3

Regulation 21 CFR 866.3700

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LIR Class 2

Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae

Clearances 3

Regulation 21 CFR 866.3390

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LOP Class 2

Solution, Antimicrobial

Clearances 3

Regulation 21 CFR 866.1640

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LRF Class 2

Candida Spp., Direct Antigen, Id

Clearances 3

Regulation 21 CFR 866.3165

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MJD Class 2

Culture Media, Antimycobacteria, Susceptibility Test

Clearances 3

Regulation 21 CFR 866.1700

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MZO Class 2

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

Clearances 3

Regulation 21 CFR 866.3169

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NTM Class 2

Antigen, Inflammatory Response Marker, Sepsis

Clearances 3

Regulation 21 CFR 866.3210

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NZB Class 2

Quality Control Material, Genetics, Dna

Clearances 3

Regulation 21 CFR 866.5910

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NZS Class 1

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast

Clearances 3

Regulation 21 CFR 866.2660

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OOU Class 2

Parainfluenza Multiplex Nucleic Acid Assay

Clearances 3

Regulation 21 CFR 866.3980

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OPL Class 2

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Clearances 3

Regulation 21 CFR 866.3510

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PAB Class 2

Cytomegalovirus (Cmv) Dna Quantitative Assay

Clearances 3

Regulation 21 CFR 866.3180

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PEX Class 2

System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Clearances 3

Regulation 21 CFR 866.3361

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PLO Class 2

Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

Clearances 3

Regulation 21 CFR 866.3970

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PMY Class 2

System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Clearances 3

Regulation 21 CFR 866.1640

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PTJ Class 2

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Clearances 3

Regulation 21 CFR 866.1640

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QBN Class 2

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Clearances 3

Regulation 21 CFR 866.3378

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QFO Class 2

Zika Virus Serological Reagents

Clearances 3

Regulation 21 CFR 866.3935

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QLX Class 2

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

Clearances 3

Regulation 21 CFR 866.3183

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QUT Class 2

Deformability Cytometry For Sepsis Risk Assessment

Clearances 3

Regulation 21 CFR 866.3215

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QVP Class 2

Sars-Cov-2 Serology Test

Clearances 3

Regulation 21 CFR 866.3983

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QWR Class 2

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Clearances 3

Regulation 21 CFR 866.3982

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QZX Class 2

Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

Clearances 3

Regulation 21 CFR 866.1650

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GMY Class 1

Antisera, Fluorescent, All Types, Escherichia Coli

Clearances 2

Regulation 21 CFR 866.3255

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GNG Class 1

Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6

Clearances 2

Regulation 21 CFR 866.3145

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GNH Class 1

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni

Clearances 2

Regulation 21 CFR 866.3600

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GNL Class 1

Antigens, Cf (Including Cf Control), Echovirus 1-34

Clearances 2

Regulation 21 CFR 866.3205

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GOI Class 2

Antiserum, Fluorescent, Rabies Virus

Clearances 2

Regulation 21 CFR 866.3460

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GOM Class 2

Antisera, Cf, Rubella

Clearances 2

Regulation 21 CFR 866.3510

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GPG Class 1

Antigen, Latex Agglutination, Trichinella Spiralis

Clearances 2

Regulation 21 CFR 866.3850

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GPJ Class 1

Antiserum, Fluorescent, Q Fever

Clearances 2

Regulation 21 CFR 866.3500

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GQC Class 1

Antisera, Cf, Equine Encephalitis Virus, Eee, Wee

Clearances 2

Regulation 21 CFR 866.3240

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GQP Class 1

Antisera, Neutralization, Parainfluenza Virus 1-4

Clearances 2

Regulation 21 CFR 866.3400

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GRB Class 1

Antiserum, Cf, Mumps Virus

Clearances 2

Regulation 21 CFR 866.3380

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GRF Class 1

Antiserum, Cf, Rubeola

Clearances 2

Regulation 21 CFR 866.3520

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GRJ Class 1

Antigen, Cf, (Including Cf Control), Rubeola

Clearances 2

Regulation 21 CFR 866.3520

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GRL Class 2

Antigens, All Groups, Salmonella Spp.

Clearances 2

Regulation 21 CFR 866.3550

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GRY Class 2

Antigens, All, Leptospira Spp.

Clearances 2

Regulation 21 CFR 866.3350

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GTI Class 2

Antisera, Fluorescent, All Groups, N. Meningitidis

Clearances 2

Regulation 21 CFR 866.3390

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GTX Class 1

Antisera, Fluorescent, All Groups, Streptococcus Spp.

Clearances 2

Regulation 21 CFR 866.3740

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GWB Class 1

Antisera, Fluorescent, All Types, Streptococcus Pneumoniae

Clearances 2

Regulation 21 CFR 866.3740

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GWD Class 2

Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp

Clearances 2

Regulation 21 CFR 866.3220

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JRW Class 1

Antisera, Fluorescent, B. Parapertussis

Clearances 2

Regulation 21 CFR 866.3065

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JTB Class 1

Device, Media Dispensing/Stacking

Clearances 2

Regulation 21 CFR 866.2440

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LOO Class 1

Reagent, Leishmanii Serological

Clearances 2

Regulation 21 CFR 866.3870

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LQH Class 2

Dna-Reagents, Legionella

Clearances 2

Regulation 21 CFR 866.3300

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LTX Class 2

Discs, Elution

Clearances 2

Regulation 21 CFR 866.1620

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MCC Class 2

Dna-Probe, Haemophilus Spp.

Clearances 2

Regulation 21 CFR 866.3300

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MCE Class 1

Respiratory Syncytial Virus - Elisa

Clearances 2

Regulation 21 CFR 866.3480

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MDU Class 2

Antigen, Elisa, Cryptococcus

Clearances 2

Regulation 21 CFR 866.3165

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MIZ Class 2

Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

Clearances 2

Regulation 21 CFR 866.3320

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MJL Class 2

Eia, Blastomyces Dermatitidis

Clearances 2

Regulation 21 CFR 866.3060

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MJM Class 1

Dna Probe, Gardnerella Vaginalis

Clearances 2

Regulation 21 CFR 866.2660

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MLA Class 1

Dna Probe, Yeast

Clearances 2

Regulation 21 CFR 866.2660

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MXB Class 1

Test, Vaginal, Bacterial Sialidase

Clearances 2

Regulation 21 CFR 866.2660

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NXD Class 2

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

Clearances 2

Regulation 21 CFR 866.3332

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OEH Class 2

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Clearances 2

Regulation 21 CFR 866.3280

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OMI Class 2

Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

Clearances 2

Regulation 21 CFR 866.3510

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OUS Class 1

Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

Clearances 2

Regulation 21 CFR 866.2050

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OZX Class 2

Mycoplasma Pneumoniae Dna Assay System

Clearances 2

Regulation 21 CFR 866.3980

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PEO Class 2

Fungal Organisms, Nucleic Acid-Based Assay

Clearances 2

Regulation 21 CFR 866.3365

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PII Class 2

Candida Species Nucleic Acid Detection System

Clearances 2

Regulation 21 CFR 866.3960

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PPU Class 2

Microbial Colony Image Assessment System

Clearances 2

Regulation 21 CFR 866.2190

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QBX Class 2

Direct Blood Bacterial Nucleic Acid Detection System

Clearances 2

Regulation 21 CFR 866.3960

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QDP Class 2

Respiratory Panel

Clearances 2

Regulation 21 CFR 866.3985

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QMI Class 2

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

Clearances 2

Regulation 21 CFR 866.3183

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QMV Class 2

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Clearances 2

Regulation 21 CFR 866.3966

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QNJ Class 2

Mass Spectrometry, Microorganism Identification, Blood Culture

Clearances 2

Regulation 21 CFR 866.3378

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QQY Class 2

Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms

Clearances 2

Regulation 21 CFR 866.2190

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QWB Class 2

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Clearances 2

Regulation 21 CFR 866.3984

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QXA Class 2

Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

Clearances 2

Regulation 21 CFR 866.3230

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GMA Class 1

Antisera, Fluorescent, Sporothrix Schenekii

Clearances 1

Regulation 21 CFR 866.3680

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GNE Class 1

Antigen, Latex Agglutination, T. Cruzi

Clearances 1

Regulation 21 CFR 866.3870

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GNJ Class 1

Antigens, Ha, Echovirus 1-34

Clearances 1

Regulation 21 CFR 866.3205

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GNN Class 1

Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6

Clearances 1

Regulation 21 CFR 866.3145

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GNO Class 1

Antisera, Cf, Coxsackievirus A 1-24, B 1-6

Clearances 1

Regulation 21 CFR 866.3145

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GNR Class 1

Antisera, Neutralization, Influenza Virus A, B, C

Clearances 1

Regulation 21 CFR 866.3330

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GOA Class 1

Antisera, Cf, Adenovirus 1-33

Clearances 1

Regulation 21 CFR 866.3020

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GOB Class 1

Antigens, Ha (Including Ha Control), Adenovirus 1-33

Clearances 1

Regulation 21 CFR 866.3020

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GOX Class 1

Antigen, B. Pertussis

Clearances 1

Regulation 21 CFR 866.3065

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GOY Class 1

Antisera, Agglutinating, B. Pertussis, All

Clearances 1

Regulation 21 CFR 866.3065

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GPF Class 1

Antigen, Agglutinating, Echinococcus Spp.

Clearances 1

Regulation 21 CFR 866.3200

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GPM Class 1

Antiserum, Murine Typhus Fever

Clearances 1

Regulation 21 CFR 866.3500

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GPN Class 1

Antiserum, Typhus Fever

Clearances 1

Regulation 21 CFR 866.3500

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GPO Class 1

Antigen, Cf, Typhus Fever Group

Clearances 1

Regulation 21 CFR 866.3500

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GPP Class 1

Antiserum, Rocky Mountain Spotted Fever

Clearances 1

Regulation 21 CFR 866.3500

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GPS Class 1

Antigen, Cf, Q Fever

Clearances 1

Regulation 21 CFR 866.3500

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GPT Class 1

Antiserum, Cf, Psittacosis (Chlamydia Group)

Clearances 1

Regulation 21 CFR 866.3120

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GQQ Class 1

Antisera, Hai, Parainfluenza Virus 1-4

Clearances 1

Regulation 21 CFR 866.3400

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GQR Class 1

Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4

Clearances 1

Regulation 21 CFR 866.3400

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GRD Class 1

Antiserum, Hai, Mumps Virus

Clearances 1

Regulation 21 CFR 866.3380

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GRT Class 1

Antiserum, Fluorescent, Mycobacterium Tuberculosis

Clearances 1

Regulation 21 CFR 866.3370

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GSH Class 1

Antisera, All Types, Listeria Monocytogenes

Clearances 1

Regulation 21 CFR 866.3355

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GSI Class 1

Antigens, Slide And Tube, All Types, Listeria Monocytogenes

Clearances 1

Regulation 21 CFR 866.3355

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GSJ Class 2

Antiserum, Fluorescent, Francisella Tularensis

Clearances 1

Regulation 21 CFR 866.3280

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GSK Class 2

Antiserum, Francisella Tularensis

Clearances 1

Regulation 21 CFR 866.3280

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GSL Class 2

Antigens, Slide And Tube, Francisella Tularensis

Clearances 1

Regulation 21 CFR 866.3280

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GSS Class 2

Antisera, Fluorescent, Pseudomonas Aeruginosa

Clearances 1

Regulation 21 CFR 866.3415

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GTC Class 1

Antisera, All Types, Klebsiella Spp.

Clearances 1

Regulation 21 CFR 866.3340

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GTR Class 1

Antideoxyribonuclease, Streptococcus Spp.

Clearances 1

Regulation 21 CFR 866.3720

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JSR Class 1

Kit, Identification, Dermatophyte

Clearances 1

Regulation 21 CFR 866.2660

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JSZ Class 1

Kit, Identification, Pseudomonas

Clearances 1

Regulation 21 CFR 866.2660

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JTM Class 1

Anaerobic Box Glove

Clearances 1

Regulation 21 CFR 866.2120

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JWK Class 2

Antigen, Positive Control, Cryptococcus Neoformans

Clearances 1

Regulation 21 CFR 866.3165

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KLH Class 1

Antisera, C. Acnes

Clearances 1

Regulation 21 CFR 866.3140

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KZB Class 1

Automated Colony Counter

Clearances 1

Regulation 21 CFR 866.2170

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LIA Class 2

Antigens, All Groups, Shigella Spp.

Clearances 1

Regulation 21 CFR 866.3660

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LOM Class 2

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Clearances 1

Regulation 21 CFR 866.3172

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LQG Class 1

Dna-Reagents, Mycoplasma Spp.

Clearances 1

Regulation 21 CFR 866.3375

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LTS Class 1

Test Reagents, Neisseria Gonorrhoeae Biochemical

Clearances 1

Regulation 21 CFR 866.2660

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MBT Class 2

Dna-Probe, Reagent, Histoplasma Capsulatum

Clearances 1

Regulation 21 CFR 866.3320

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MCS Class 1

Dna-Probe, Staphylococcus Aureus

Clearances 1

Regulation 21 CFR 866.3700

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MCT Class 1

Dna-Probe, Strep Pneumoniae

Clearances 1

Regulation 21 CFR 866.3740

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MDC Class 2

Dna-Probe - Blastomyces Dermatitidis

Clearances 1

Regulation 21 CFR 866.3060

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MDE Class 2

Dna-Probe, Reagents, Cryptococcal

Clearances 1

Regulation 21 CFR 866.3165

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MDF Class 2

Dna-Probe, Reagents, Coccidioides Immitis

Clearances 1

Regulation 21 CFR 866.3135

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MDJ Class 1

Reagents, Cysticercosis

Clearances 1

Regulation 21 CFR 866.3200

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MIY Class 2

Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

Clearances 1

Regulation 21 CFR 866.3135

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MJE Class 2

Culture Media, Antifungal, Susceptibility Test

Clearances 1

Regulation 21 CFR 866.1700

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MJK Class 1

Dna Probe, Trichomonas Vaginalis

Clearances 1

Regulation 21 CFR 866.2660

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NDZ Class 1

Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis

Clearances 1

Regulation 21 CFR 866.3370

View devices →

NGS Class 2

Assay, Endotoxin Activity, Chemiluminescent

Clearances 1

Regulation 21 CFR 866.3210

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NJO Class 1

System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

Clearances 1

Regulation 21 CFR 866.3370

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NPO Class 2

Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

Clearances 1

Regulation 21 CFR 866.3045

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NQZ Class 2

Antigen, Invasive Fungal Pathogens

Clearances 1

Regulation 21 CFR 866.3050

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NRL Class 2

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

Clearances 1

Regulation 21 CFR 866.3045

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NVQ Class 2

Bacteriophage And Controls, B. Anthracis Lysis

Clearances 1

Regulation 21 CFR 866.3045

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NWZ Class 2

Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

Clearances 1

Regulation 21 CFR 866.3045

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OAI Class 2

Assay, Enterovirus Nucleic Acid

Clearances 1

Regulation 21 CFR 866.3225

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OMS Class 2

Novel Influenza A Virus, A/H5 Ns1 Protein

Clearances 1

Regulation 21 CFR 866.3332

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OPM Class 2

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

Clearances 1

Regulation 21 CFR 866.3510

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OUZ Class 1

Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

Clearances 1

Regulation 21 CFR 866.3870

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OVF Class 1

Assay, Direct, Nucleic Acid Amplification, Q Fever

Clearances 1

Regulation 21 CFR 866.3500

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OWF Class 1

Immunohistochemical Assay, Helicobacter Pylori

Clearances 1

Regulation 21 CFR 866.3110

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OYP Class 2

Anti-Jcv Antibody Detection Assay

Clearances 1

Regulation 21 CFR 866.3336

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OYZ Class 1

Group A Streptococcus Nucleic Acid Amplification Assay System

Clearances 1

Regulation 21 CFR 866.3740

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PGH Class 2

Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

Clearances 1

Regulation 21 CFR 866.3307

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PIQ Class 2

Reagents For Detection Of Norovirus Nucleic Acid

Clearances 1

Regulation 21 CFR 866.3990

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PRH Class 2

Positive Blood Culture Identification And Ast Kit

Clearances 1

Regulation 21 CFR 866.1650

View devices →

PUQ Class 2

Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

Clearances 1

Regulation 21 CFR 866.3510

View devices →

PVQ Class 2

Rickettsia Spp. Nucleic Acid Based Detection Assay

Clearances 1

Regulation 21 CFR 866.3316

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QBH Class 2

Lower Respiratory Microbial Nucleic Acid Detection System

Clearances 1

Regulation 21 CFR 866.3985

View devices →

QBQ Class 1

System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

Clearances 1

Regulation 21 CFR 866.2560

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QCH Class 2

Assayed Quality Control Material For Clinical Microbiology Assays

Clearances 1

Regulation 21 CFR 866.3920

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QCU Class 2

Dengue Virus Antigen Assay

Clearances 1

Regulation 21 CFR 866.3945

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QDZ Class 2

Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Clearances 1

Regulation 21 CFR 866.3181

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QFS Class 2

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Clearances 1

Regulation 21 CFR 866.3215

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QGN Class 2

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

Clearances 1

Regulation 21 CFR 866.3230

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QUU Class 2

Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

Clearances 1

Regulation 21 CFR 866.3046

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QYA Class 2

System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

Clearances 1

Regulation 21 CFR 866.3385

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SCX Class 2

Immunoassay For Host Biomarkers Of Sepsis

Clearances 1

Regulation 21 CFR 866.3215

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SEP Class 2

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

Clearances 1

Regulation 21 CFR 866.2920

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SIA Class 2

Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test

Clearances 1

Regulation 21 CFR 866.3984

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SIH Class 2

Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay

Clearances 1

Regulation 21 CFR 866.2920

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GMB Class 1

Light, Wood'S, Fluorescence

Clearances 0

Regulation 21 CFR 866.2600

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GME Class 2

Antisera, Fluorescent, Cryptococcus Neoformans

Clearances 0

Regulation 21 CFR 866.3165

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GML Class 2

Antisera, Fluorescent, Histoplasma Capsulatum

Clearances 0

Regulation 21 CFR 866.3320

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GMO Class 2

Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.

Clearances 0

Regulation 21 CFR 866.3220

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GMR Class 2

Sera, Reactive And Non-Specific Control, Fta-Abs Test

Clearances 0

Regulation 21 CFR 866.3830

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GMW Class 2

Test, Sorbent, Fta-Abs

Clearances 0

Regulation 21 CFR 866.3830

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GMX Class 2

Antisera, Fluorescent Antibody For Fta-Abs Test

Clearances 0

Regulation 21 CFR 866.3830

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GND Class 1

Antigen, Iha, T. Cruzi

Clearances 0

Regulation 21 CFR 866.3870

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GNF Class 1

Antigen, Cf, T. Cruzi

Clearances 0

Regulation 21 CFR 866.3870

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GNI Class 1

Antisera, Neutralization, Echovirus 1-34

Clearances 0

Regulation 21 CFR 866.3205

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GNQ Class 1

Antigen, Cf (Including Cf Control), Epstein-Barr Virus

Clearances 0

Regulation 21 CFR 866.3235

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GNZ Class 1

Antisera, Neutralization, Adenovirus 1-33

Clearances 0

Regulation 21 CFR 866.3020

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GOC Class 1

Antisera, Hai, Adenovirus 1-33

Clearances 0

Regulation 21 CFR 866.3020

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GOF Class 1

Antisera, Neutralization, Poliovirus 1-3

Clearances 0

Regulation 21 CFR 866.3405

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GOH Class 1

Antigens, Cf (Including Cf Control), Poliovirus 1-3

Clearances 0

Regulation 21 CFR 866.3405

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GOJ Class 2

Antisera, Neutralization, Rubella

Clearances 0

Regulation 21 CFR 866.3510

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GOO Class 2

Antisera, Fluorescent, All Globulins, Salmonella Spp.

Clearances 0

Regulation 21 CFR 866.3550

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GOP Class 1

Antisera, C. Acnes (553, 605)

Clearances 0

Regulation 21 CFR 866.3140

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GOS Class 1

Antiserum, Fluorescent, C. Diphtheriae

Clearances 0

Regulation 21 CFR 866.3140

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GOT Class 1

Antigen, B. Parapertussis

Clearances 0

Regulation 21 CFR 866.3065

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GOW Class 1

Antisera, Agglutinating, B. Parapertussis

Clearances 0

Regulation 21 CFR 866.3065

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GOZ Class 1

Antisera, Fluorescent, B. Pertussis

Clearances 0

Regulation 21 CFR 866.3065

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GPD Class 1

Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus

Clearances 0

Regulation 21 CFR 866.3200

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GPE Class 1

Antisera, Positive Control, Echinococcus Spp.

Clearances 0

Regulation 21 CFR 866.3200

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GPH Class 1

Antiserum, Bentonite Flocculation, Trichinella Spiralis

Clearances 0

Regulation 21 CFR 866.3850

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GPI Class 1

Antigen, Bentonite Flocculation, Trichinella Spiralis

Clearances 0

Regulation 21 CFR 866.3850

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GPK Class 1

Antiserum, Rickettsial Pox

Clearances 0

Regulation 21 CFR 866.3500

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GPQ Class 1

Antigen, Cf, Spotted Fever Group

Clearances 0

Regulation 21 CFR 866.3500

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GPR Class 1

Antiserum, Cf, Q Fever

Clearances 0

Regulation 21 CFR 866.3500

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GPX Class 1

Antisera, Neutralizion, Reovirus 1-3

Clearances 0

Regulation 21 CFR 866.3470

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GPY Class 1

Antisera, Hai, Reovirus 1-3

Clearances 0

Regulation 21 CFR 866.3470

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GPZ Class 1

Antisera, Cf, Reovirus 1-3

Clearances 0

Regulation 21 CFR 866.3470

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GQA Class 1

Antigens, Ha (Including Ha Control), Reovirus 1-3

Clearances 0

Regulation 21 CFR 866.3470

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GQB Class 1

Antigens, Cf (Including Cf Control), Reovirus 1-3

Clearances 0

Regulation 21 CFR 866.3470

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GQD Class 1

Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee

Clearances 0

Regulation 21 CFR 866.3240

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GQE Class 1

Antisera, Neutralization, All Types, Rhinovirus

Clearances 0

Regulation 21 CFR 866.3490

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GQF Class 1

Antiserum, Neutralization, Respiratory Syncytial Virus

Clearances 0

Regulation 21 CFR 866.3480

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GQJ Class 1

Antiserum, Cf, Lymphocytic Choriomeningitis Virus

Clearances 0

Regulation 21 CFR 866.3360

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GQK Class 1

Antigen, Cf, Lymphocytic Choriomeningitis Virus

Clearances 0

Regulation 21 CFR 866.3360

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GQY Class 1

Antigen, Ha (Including Ha Control), Mumps Virus

Clearances 0

Regulation 21 CFR 866.3380

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GQZ Class 1

Antiserum, Neutralization, Mumps Virus

Clearances 0

Regulation 21 CFR 866.3380

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GRG Class 1

Antiserum, Hai, Rubeola

Clearances 0

Regulation 21 CFR 866.3520

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GRH Class 1

Antigen, Ha (Including Ha Control), Rubeola

Clearances 0

Regulation 21 CFR 866.3520

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GRI Class 1

Antiserum, Neutralization, Rubeola

Clearances 0

Regulation 21 CFR 866.3520

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GRK Class 1

Antisera, Fluorescent, Echovirus 1-34

Clearances 0

Regulation 21 CFR 866.3205

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GRW Class 2

Antisera, All Fluorescent, Leptospira Spp.

Clearances 0

Regulation 21 CFR 866.3350

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GRX Class 2

Antisera, All Leptospira Spp.

Clearances 0

Regulation 21 CFR 866.3350

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GSD Class 1

Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae

Clearances 0

Regulation 21 CFR 866.3250

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GSE Class 1

Antiserum, Erysipelothrix Rhusiopathiae

Clearances 0

Regulation 21 CFR 866.3250

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GSF Class 1

Antigen, Erysipelothrix Rhusiopathiae

Clearances 0

Regulation 21 CFR 866.3250

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GSG Class 1

Antisera, Fluorescent, All Types, Listeria Monocytogenes

Clearances 0

Regulation 21 CFR 866.3355

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GSP Class 1

Antiserum, Fluorescent, Campylobacter Fetus

Clearances 0

Regulation 21 CFR 866.3110

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GSR Class 2

Antisera, Fluorescent, Pseudomonas Pseudomallei

Clearances 0

Regulation 21 CFR 866.3415

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GST Class 2

Antiserum, Pseudomonas Pseudomallei

Clearances 0

Regulation 21 CFR 866.3415

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GSW Class 1

Antiserum, Flavobacterium Meningosepticum, All Groups

Clearances 0

Regulation 21 CFR 866.3270

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GSX Class 1

Antisera, Acinetobacter Calcoaceticus, All Varieties

Clearances 0

Regulation 21 CFR 866.3010

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GSY Class 1

Antisera, Fluorescent, All Globulins, Proteus Spp.

Clearances 0

Regulation 21 CFR 866.3410

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GTA Class 1

Antisera, All, Serratia Marcesans

Clearances 0

Regulation 21 CFR 866.3630

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GTB Class 1

Antisera, Fluorescent, All Types, Klebsiella Spp.

Clearances 0

Regulation 21 CFR 866.3340

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GTD Class 2

Antisera, Fluorescent, All Globulins, Shigella Spp.

Clearances 0

Regulation 21 CFR 866.3660

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GTE Class 1

Antisera, Arizona Spp., All

Clearances 0

Regulation 21 CFR 866.3035

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GTF Class 1

Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.

Clearances 0

Regulation 21 CFR 866.3125

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GTL Class 1

Phages, Staphylococcal Typing, All Types

Clearances 0

Regulation 21 CFR 866.2050

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GTO Class 1

Anti-Streptokinase

Clearances 0

Regulation 21 CFR 866.3720

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JRZ Class 1

Media, Culture, Amino Acid Assay

Clearances 0

Regulation 21 CFR 866.2350

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JSB Class 1

Culture Media, Vitamin Assay

Clearances 0

Regulation 21 CFR 866.2350

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KFI Class 1

Strip, Virulence, Corynebacterium Diphtheriae

Clearances 0

Regulation 21 CFR 866.3140

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KZC Class 1

Manual Colony Counter

Clearances 0

Regulation 21 CFR 866.2180

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LGA Class 3

Device, Oxidase Test For Gonorrhea

Clearances 0

Regulation 21 CFR 866.2420

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LGB Class 3

Gonococcal Antibody Tests

Clearances 0

Regulation 21 CFR 866.3290

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LKC Class 2

Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus

Clearances 0

Regulation 21 CFR 866.3305

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LSD Class 2

Rubella, Other Assays

Clearances 0

Regulation 21 CFR 866.3510

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LSF Class 1

Dna-Reagents, Epstein-Barr Virus

Clearances 0

Regulation 21 CFR 866.3235

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LSG Class 2

Candida Species, Antibody Detection

Clearances 0

Regulation 21 CFR 866.3165

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LSH Class 2

Antigen, Blastomyces Dermatitidis, Other

Clearances 0

Regulation 21 CFR 866.3060

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LSI Class 2

Antiserum, Blastomyces Dermatitidis, Other

Clearances 0

Regulation 21 CFR 866.3060

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LSJ Class 2

Antigen, Rubella, Other

Clearances 0

Regulation 21 CFR 866.3510

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LSM Class 2

Dna-Reagents, Salmonella Spp.

Clearances 0

Regulation 21 CFR 866.3550

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LSN Class 2

Dna-Reagents, Shigella Spp.

Clearances 0

Regulation 21 CFR 866.3660

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LSO Class 2

Dna-Reagents, Cytomegalovirus

Clearances 0

Regulation 21 CFR 866.3175

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MCG Class 1

Dna-Probe, Agent, Listeria

Clearances 0

Regulation 21 CFR 866.3355

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MDT Class 1

Elisa, Trichinella Spiralis

Clearances 0

Regulation 21 CFR 866.3850

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MGM Class 1

C. Trachomatis (Chlamydia Group)

Clearances 0

Regulation 21 CFR 866.3120

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MIV Class 1

Immunofluorescent Assay, T. Cruzi

Clearances 0

Regulation 21 CFR 866.3870

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MKT Class 2

Hepatitis Viral B Dna Detection

Clearances 0

Regulation 21 CFR 866.3174

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MWA Class 2

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Clearances 0

Regulation 21 CFR 866.3372

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MYR Class 2

Test, Donor, Syphilis, Antigens, Treponemal

Clearances 0

Regulation 21 CFR 866.3830

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MZC Class 1

System, Detection, Bacterial, For Platelet Transfusion Products

Clearances 0

Regulation 21 CFR 866.2560

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MZF Class 2

Test, Hiv Detection

Clearances 0

Regulation 21 CFR 866.3956

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NHY Class 1

Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus

Clearances 0

Regulation 21 CFR 866.3480

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NHZ Class 1

Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus

Clearances 0

Regulation 21 CFR 866.3400

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NIA Class 1

Assay, Direct, Nucleic Acid Amplification, Influenza Virus

Clearances 0

Regulation 21 CFR 866.3330

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OAX Class 2

Plasmodium Spp. Detection Reagents

Clearances 0

Regulation 21 CFR 866.3402

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OBF Class 2

Assay, Genotyping, Hepatitis C Virus

Clearances 0

Regulation 21 CFR 866.3170

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OEP Class 2

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

Clearances 0

Regulation 21 CFR 866.3980

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OID Class 1

Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)

Clearances 0

Regulation 21 CFR 866.2900

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OJY Class 2

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

Clearances 0

Regulation 21 CFR 866.3236

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OSU Class 2

Dengue Serological Reagents

Clearances 0

Regulation 21 CFR 866.3945

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OTG Class 2

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

Clearances 0

Regulation 21 CFR 866.3980

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OUC Class 2

Norovirus Serological Reagent

Clearances 0

Regulation 21 CFR 866.3395

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OZA Class 3

Test, Urea Adult And Pediatric (Breath),

Clearances 0

Regulation 21 CFR 866.3110

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OZB Class 2

Dengue Nucleic Acid Amplification Assay (Naat)

Clearances 0

Regulation 21 CFR 866.3946

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OZY Class 2

Chlamydophila Pneumoniae Dna Assay System

Clearances 0

Regulation 21 CFR 866.3980

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PCL Class 1

Enzyme Linked Immunoabsorbent Assay, Rubeola Igm

Clearances 0

Regulation 21 CFR 866.3520

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PEU Class 2

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

Clearances 0

Regulation 21 CFR 866.3373

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PGV Class 2

Anti-Phospholipase A2 Receptor

Clearances 0

Regulation 21 CFR 866.5780

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PIT Class 1

Leishmania Spp. Antigen Detection Assay

Clearances 0

Regulation 21 CFR 866.3870

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PRA Class 2

Variola Virus Nucleic Acid-Based Detection Assay

Clearances 0

Regulation 21 CFR 866.3316

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PYN Class 2

Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

Clearances 0

Regulation 21 CFR 866.3367

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QAA Class 2

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Clearances 0

Regulation 21 CFR 866.3376

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QFA Class 2

Assay For Detection Of Proteases In Chronic Wounds

Clearances 0

Regulation 21 CFR 866.3231

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QHM Class U

Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

Clearances 0

Regulation 21 CFR 610.40

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QHO Class U

Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

Clearances 0

Regulation 21 CFR 610.40

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QID Class 2

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Clearances 0

Regulation 21 CFR 866.4002

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QIG Class 2

Quality Control Material, Genetics, Rna

Clearances 0

Regulation 21 CFR 866.5910

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QIV Class 2

Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

Clearances 0

Regulation 21 CFR 866.1655

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QMC Class 1

Transport Medium, Notified Per The Vtm Guidance

Clearances 0

Regulation 21 CFR 866.2390

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QPO Class 2

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Clearances 0

Regulation 21 CFR 866.2952

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QSN Class 2

Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

Clearances 0

Regulation 21 CFR 866.3988

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QST Class 2

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

Clearances 0

Regulation 21 CFR 866.3957

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QSU Class 2

Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

Clearances 0

Regulation 21 CFR 866.3956

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QSV Class 2

Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

Clearances 0

Regulation 21 CFR 866.3957

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QTM Class 2

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

Clearances 0

Regulation 21 CFR 866.3920

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QUM Class 2

Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test

Clearances 0

Regulation 21 CFR 866.3958

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SBP Class 2

Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

Clearances 0

Regulation 21 CFR 866.3171

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SBT Class 2

Device To Detect Microbial Colonization Directly From Clinical Specimens.

Clearances 0

Regulation 21 CFR 866.3967

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SBZ Class 2

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Clearances 0

Regulation 21 CFR 866.3986

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SCU Class 2

Dna And Rna Oncology Controls

Clearances 0

Regulation 21 CFR 866.5910

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SEA Class 2

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Clearances 0

Regulation 21 CFR 866.3386

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