Immunology Device Classification Codes

3465 FDA 510(k) clearances across 289 product codes.

DHB Class 2

System, Test, Radioallergosorbent (Rast) Immunological

Clearances 267

Regulation 21 CFR 866.5750

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LLL Class 2

Extractable Antinuclear Antibody, Antigen And Control

Clearances 179

Regulation 21 CFR 866.5100

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DHR Class 2

System, Test, Rheumatoid Factor

Clearances 143

Regulation 21 CFR 866.5775

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DCK Class 2

C-Reactive Protein, Antigen, Antiserum, And Control

Clearances 124

Regulation 21 CFR 866.5270

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DGC Class 2

Ige, Antigen, Antiserum, Control

Clearances 113

Regulation 21 CFR 866.5510

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LJM Class 2

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Clearances 109

Regulation 21 CFR 866.5100

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DHN Class 2

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Clearances 107

Regulation 21 CFR 866.5100

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MID Class 2

System, Test, Anticardiolipin Immunological

Clearances 94

Regulation 21 CFR 866.5660

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JZO Class 2

System, Test, Thyroid Autoantibody

Clearances 92

Regulation 21 CFR 866.5870

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DBF Class 2

Ferritin, Antigen, Antiserum, Control

Clearances 86

Regulation 21 CFR 866.5340

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DEW Class 2

Igg, Antigen, Antiserum, Control

Clearances 76

Regulation 21 CFR 866.5510

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MOB Class 2

Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Clearances 74

Regulation 21 CFR 866.5660

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DCN Class 2

System, Test, C-Reactive Protein

Clearances 70

Regulation 21 CFR 866.5270

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DFH Class 2

Kappa, Antigen, Antiserum, Control

Clearances 62

Regulation 21 CFR 866.5550

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KTN Class 2

System, Test, Infectious Mononucleosis

Clearances 59

Regulation 21 CFR 866.5640

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CFN Class 2

Method, Nephelometric, Immunoglobulins (G, A, M)

Clearances 58

Regulation 21 CFR 866.5510

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CZP Class 2

Iga, Antigen, Antiserum, Control

Clearances 54

Regulation 21 CFR 866.5510

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JZG Class 2

System, Test, Beta-2-Microglobulin Immunological

Clearances 53

Regulation 21 CFR 866.5630

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DEH Class 2

Lambda, Antigen, Antiserum, Control

Clearances 52

Regulation 21 CFR 866.5550

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LKJ Class 2

Antinuclear Antibody, Antigen, Control

Clearances 50

Regulation 21 CFR 866.5100

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DDG Class 2

Transferrin, Antigen, Antiserum, Control

Clearances 48

Regulation 21 CFR 866.5880

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DDR Class 2

Myoglobin, Antigen, Antiserum, Control

Clearances 46

Regulation 21 CFR 866.5680

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CZW Class 2

Complement C3, Antigen, Antiserum, Control

Clearances 44

Regulation 21 CFR 866.5240

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MSV Class 2

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Clearances 44

Regulation 21 CFR 866.5660

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DFC Class 2

Lipoprotein, Low-Density, Antigen, Antiserum, Control

Clearances 43

Regulation 21 CFR 866.5600

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MST Class 2

Antibodies, Gliadin

Clearances 42

Regulation 21 CFR 866.5750

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MVM Class 2

Autoantibodies, Endomysial(Tissue Transglutaminase)

Clearances 39

Regulation 21 CFR 866.5660

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DCF Class 2

Albumin, Antigen, Antiserum, Control

Clearances 35

Regulation 21 CFR 866.5040

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DBI Class 2

Complement C4, Antigen, Antiserum, Control

Clearances 34

Regulation 21 CFR 866.5240

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LTJ Class 2

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Clearances 34

Regulation 21 CFR 866.6010

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DFT Class 2

Igm, Antigen, Antiserum, Control

Clearances 33

Regulation 21 CFR 866.5550

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DEM Class 2

Alpha-1-Antitrypsin, Antigen, Antiserum, Control

Clearances 30

Regulation 21 CFR 866.5130

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LRM Class 2

Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Clearances 29

Regulation 21 CFR 866.5100

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CFF Class 2

Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Clearances 28

Regulation 21 CFR 866.5510

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DAK Class 2

Complement C1q, Antigen, Antiserum, Control

Clearances 28

Regulation 21 CFR 866.5240

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DHX Class 2

System, Test, Carcinoembryonic Antigen

Clearances 28

Regulation 21 CFR 866.6010

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MOI Class 2

System, Test, Immunological, Antigen, Tumor

Clearances 28

Regulation 21 CFR 866.6010

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LKP Class 2

Anti-Sm Antibody, Antigen And Control

Clearances 27

Regulation 21 CFR 866.5100

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DBM Class 2

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Clearances 26

Regulation 21 CFR 866.5090

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DBL Class 2

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Clearances 24

Regulation 21 CFR 866.5660

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JMG Class 2

Radioimmunoassay (Two-Site Solid Phase), Ferritin

Clearances 24

Regulation 21 CFR 866.5340

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LTK Class 2

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

Clearances 24

Regulation 21 CFR 866.6010

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JNL Class 2

Immunochemical, Thyroglobulin Autoantibody

Clearances 22

Regulation 21 CFR 866.5870

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LKO Class 2

Anti-Rnp Antibody, Antigen And Control

Clearances 22

Regulation 21 CFR 866.5100

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NHX Class 2

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Clearances 20

Regulation 21 CFR 866.5775

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DDB Class 2

Ceruloplasmin, Antigen, Antiserum, Control

Clearances 19

Regulation 21 CFR 866.5210

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KTL Class 2

Anti-Dna Indirect Immunofluorescent Solid Phase

Clearances 19

Regulation 21 CFR 866.5100

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NQD Class 2

Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Clearances 19

Regulation 21 CFR 866.5270

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DAD Class 2

Haptoglobin, Antigen, Antiserum, Control

Clearances 18

Regulation 21 CFR 866.5460

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DER Class 2

Alpha-1-Lipoprotein, Antigen, Antiserum, Control

Clearances 17

Regulation 21 CFR 866.5580

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LOJ Class 2

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

Clearances 17

Regulation 21 CFR 866.6010

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DHC Class 2

System, Test, Systemic Lupus Erythematosus

Clearances 16

Regulation 21 CFR 866.5820

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DGO Class 2

Ige, Peroxidase, Antigen, Antiserum, Control

Clearances 15

Regulation 21 CFR 866.5510

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JZT Class 1

Fluorometer

Clearances 14

Regulation 21 CFR 866.4520

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DDC Class 2

Thyroglobulin, Antigen, Antiserum, Control

Clearances 13

Regulation 21 CFR 866.5870

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MSW Class 2

System, Test, Thyroglobulin

Clearances 13

Regulation 21 CFR 866.6010

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NXO Class 2

Calprotectin, Fecal

Clearances 13

Regulation 21 CFR 866.5180

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CFQ Class 2

Radioimmunoassay, Immunoglobulins (G, A, M)

Clearances 12

Regulation 21 CFR 866.5510

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DBA Class 2

Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

Clearances 12

Regulation 21 CFR 866.5250

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DEB Class 2

Alpha-2-Macroglobulin, Antigen, Antiserum, Control

Clearances 12

Regulation 21 CFR 866.5620

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NIG Class 2

System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Clearances 12

Regulation 21 CFR 866.6010

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NQI Class 2

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

Clearances 12

Regulation 21 CFR 866.6020

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JZJ Class 1

Prealbumin, Antigen, Antiserum, Control

Clearances 11

Regulation 21 CFR 866.5060

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JZW Class 1

Nephelometer

Clearances 11

Regulation 21 CFR 866.4540

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LKL Class 1

Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

Clearances 11

Regulation 21 CFR 866.5420

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NUA Class 2

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Clearances 11

Regulation 21 CFR 866.5900

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DDX Class 1

Plasminogen, Antigen, Antiserum, Control

Clearances 10

Regulation 21 CFR 866.5715

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DFZ Class 2

Igg (Gamma Chain Specific), Antigen, Antiserum, Control

Clearances 9

Regulation 21 CFR 866.5510

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JHR Class 2

Radioimmunoassay, Immunoglobulins (D, E)

Clearances 9

Regulation 21 CFR 866.5510

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MMW Class 2

System, Test, Tumor Marker, Monitoring, Bladder

Clearances 9

Regulation 21 CFR 866.6010

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CZJ Class 2

Igd, Antigen, Antiserum, Control

Clearances 8

Regulation 21 CFR 866.5510

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DAO Class 2

Igm (Mu Chain Specific), Antigen, Antiserum, Control

Clearances 8

Regulation 21 CFR 866.5550

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DAS Class 1

Igg (Fc Fragment Specific), Antigen, Antiserum, Control

Clearances 8

Regulation 21 CFR 866.5530

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DEG Class 1

Lactoferrin, Antigen, Antiserum, Control

Clearances 8

Regulation 21 CFR 866.5570

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LSW Class 2

Anti-Dna Antibody, Antigen And Control

Clearances 8

Regulation 21 CFR 866.5100

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CZN Class 2

Iga, Fitc, Antigen, Antiserum, Control

Clearances 7

Regulation 21 CFR 866.5510

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DAH Class 2

Gamma Globulin, Antigen, Antiserum, Control

Clearances 7

Regulation 21 CFR 866.5510

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JZQ Class 1

Plates And Equipment, Radial Immunodiffusion

Clearances 7

Regulation 21 CFR 866.4800

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NBT Class 2

Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)

Clearances 7

Regulation 21 CFR 866.5785

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NOE Class 2

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Clearances 7

Regulation 21 CFR 866.5600

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NYI Class 2

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Clearances 7

Regulation 21 CFR 866.6040

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OUY Class 2

Trichomonas Vaginalis Nucleic Acid Amplification Test System

Clearances 7

Regulation 21 CFR 866.3860

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DBE Class 2

Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

Clearances 6

Regulation 21 CFR 866.5120

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DBY Class 1

Fab, Rhodamine, Antigen, Antiserum, Control

Clearances 6

Regulation 21 CFR 866.5520

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JZH Class 2

Factor B, Antigen, Antiserum, Control

Clearances 6

Regulation 21 CFR 866.5320

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JZS Class 1

Electrophoresis Instrumentation

Clearances 6

Regulation 21 CFR 866.4500

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KTQ Class 1

Reagent, Complement

Clearances 6

Regulation 21 CFR 866.4100

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MVJ Class 2

Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

Clearances 6

Regulation 21 CFR 866.5660

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NTH Class 2

System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

Clearances 6

Regulation 21 CFR 866.4700

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DAA Class 2

Igg, Peroxidase, Antigen, Antiserum, Control

Clearances 5

Regulation 21 CFR 866.5510

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DAE Class 2

Complement C9, Antigen, Antiserum, Control

Clearances 5

Regulation 21 CFR 866.5240

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DEL Class 1

Lipoprotein X, Antigen, Antiserum, Control

Clearances 5

Regulation 21 CFR 866.5590

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DEX Class 1

Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

Clearances 5

Regulation 21 CFR 866.5420

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DGR Class 1

Whole Human Serum, Antigen, Antiserum, Control

Clearances 5

Regulation 21 CFR 866.5700

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QAT Class 2

Brain Trauma Assessment Test

Clearances 5

Regulation 21 CFR 866.5830

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CGM Class 2

Method, Immunodiffusion, Immunoglobulins (G, A, M)

Clearances 4

Regulation 21 CFR 866.5510

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DDS Class 1

Prealbumin, Fitc, Antigen, Antiserum, Control

Clearances 4

Regulation 21 CFR 866.5060

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DDZ Class 2

Albumin, Fitc, Antigen, Antiserum, Control

Clearances 4

Regulation 21 CFR 866.5040

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DFI Class 1

Total Spinal-Fluid, Antigen, Antiserum, Control

Clearances 4

Regulation 21 CFR 866.5860

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DGP Class 2

Ige, Fitc, Antigen, Antiserum, Control

Clearances 4

Regulation 21 CFR 866.5510

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DHL Class 1

Protein, Complement, Antigen, Antiserum, Control

Clearances 4

Regulation 21 CFR 866.4100

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JKM Class 2

Immunochemical, Bence-Jones Protein

Clearances 4

Regulation 21 CFR 866.5150

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KTS Class 2

Second Antibody (Species Specific Anti-Animal Gamma Globulin)

Clearances 4

Regulation 21 CFR 866.5510

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MQA Class 2

Anti-Ribosomal P Antibodies

Clearances 4

Regulation 21 CFR 866.5100

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NST Class 2

Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

Clearances 4

Regulation 21 CFR 866.5660

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NYO Class 2

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Clearances 4

Regulation 21 CFR 866.5100

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OIU Class 2

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Clearances 4

Regulation 21 CFR 866.6010

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PTA Class 2

Genetic Variant Detection And Health Risk Assessment System

Clearances 4

Regulation 21 CFR 866.5950

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SET Class 2

Immunoassay Blood Test For Amyloid Pathology Assessment

Clearances 4

Regulation 21 CFR 866.5840

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CHN Class 2

Immunochemical, Ceruloplasmin

Clearances 3

Regulation 21 CFR 866.5210

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CZS Class 1

Retinol-Binding Protein, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5765

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CZX Class 2

Hemopexin, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5490

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DAB Class 2

Haptoglobin, Fitc, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5460

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DAN Class 2

Fibrinopeptide A, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5350

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DAY Class 2

Complement C5, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5240

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DDE Class 1

Carbonic Anhydrase C, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5200

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DEY Class 2

Igm, Peroxidase, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5550

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DFD Class 2

Kappa, Peroxidase, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5550

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DFK Class 1

Igg (Fab Fragment Specific), Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5520

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DFL Class 2

Igm, Ferritin, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5550

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DGD Class 2

Igg, Ferritin, Antigen, Antiserum, Control

Clearances 3

Regulation 21 CFR 866.5510

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JNM Class 2

Immunochemical, Transferrin

Clearances 3

Regulation 21 CFR 866.5880

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MLE Class 2

Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

Clearances 3

Regulation 21 CFR 866.5110

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NBS Class 2

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

Clearances 3

Regulation 21 CFR 866.5660

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NCW Class 2

System, Test, Her-2/Neu, Monitoring

Clearances 3

Regulation 21 CFR 866.6010

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NIY Class 2

Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

Clearances 3

Regulation 21 CFR 866.5660

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OEG Class 2

Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

Clearances 3

Regulation 21 CFR 866.5660

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OIF Class 2

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

Clearances 3

Regulation 21 CFR 866.5660

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OVK Class 2

Cytokeratin Fragments 21-1 Eia Kit

Clearances 3

Regulation 21 CFR 866.6010

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OYU Class 2

Dna-Probe Kit, Human Chromosome

Clearances 3

Regulation 21 CFR 866.4700

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PCN Class 2

Immunoglobulin G Kappa Heavy And Light Chain Combined

Clearances 3

Regulation 21 CFR 866.5510

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PZH Class 2

Serpina1 Variant Detection System

Clearances 3

Regulation 21 CFR 866.5130

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PZJ Class 2

Lynch Syndrome Test System

Clearances 3

Regulation 21 CFR 864.1866

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QVR Class 2

Multiplex Nucleic Acid Detection System For Biothreat Agents

Clearances 3

Regulation 21 CFR 866.4000

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CZQ Class 2

Bence-Jones Protein, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5150

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DAC Class 2

Complement C3b Activator, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5260

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DBJ Class 2

Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control

Clearances 2

Regulation 21 CFR 866.5110

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DCE Class 1

Fab, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5520

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DDF Class 1

Prothrombin, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5735

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DDI Class 2

Transferrin, Fitc, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5880

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DEI Class 2

Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5130

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DEN Class 1

Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5420

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DEO Class 2

Kappa, Fitc, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5550

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DES Class 2

Lambda, Fitc, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5550

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DGE Class 2

Igd, Rhodamine, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5510

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DGK Class 2

Igg, Fitc, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5510

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JFR Class 2

Indirect Copper Assay, Ceruloplasmin

Clearances 2

Regulation 21 CFR 866.5210

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JZR Class 1

Support Gels

Clearances 2

Regulation 21 CFR 866.4900

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KTO Class 1

Reagent, Immunoassay, Igg

Clearances 2

Regulation 21 CFR 866.5530

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LYE Class 2

Cytokeratins

Clearances 2

Regulation 21 CFR 866.5550

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MGA Class 1

Alpha-1 Microglobulin, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 866.5400

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NBO Class 2

Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)

Clearances 2

Regulation 21 CFR 866.5660

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NRI Class 2

Autoantibodies, Nuclear Pore Glycoprotein Gp210

Clearances 2

Regulation 21 CFR 866.5090

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NTV Class 2

Myeloperoxidase, Immunoassay, System, Test

Clearances 2

Regulation 21 CFR 866.5600

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NWG Class 2

Autoantibodies, Glutamic Acid Decarboxylase (Gad)

Clearances 2

Regulation 21 CFR 866.5660

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OBE Class 2

Anti-Ss-A 52 Autoantibodies

Clearances 2

Regulation 21 CFR 866.5100

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OBZ Class 2

Alpha-1-Antitrypsin Kit, Qualitative Phenotype

Clearances 2

Regulation 21 CFR 866.5130

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OVQ Class 2

Chronic Lymphocytic Leukemia Fish Probe Kit

Clearances 2

Regulation 21 CFR 866.6040

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PCG Class 2

21-Hydroxylase Antibody (21-Ohab)

Clearances 2

Regulation 21 CFR 866.5660

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QSE Class 2

AlzheimerS Disease Pathology Assessment Test

Clearances 2

Regulation 21 CFR 866.5840

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SGA Class 2

Biothreat Microbial Agent Nucleic Acid Detection Test

Clearances 2

Regulation 21 CFR 866.4000

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CZK Class 2

Iga, Rhodamine, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5510

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CZM Class 2

Iga, Ferritin, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5510

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CZY Class 2

Complement C1s, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5240

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DAF Class 2

Gamma Globulin, Fitc, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5510

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DAQ Class 1

Igg (Fd Fragment Specific), Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5540

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DBN Class 1

Fc, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5530

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DBT Class 1

Factor Xiii A, S, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5330

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DCB Class 1

Fab, Fitc, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5520

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DCH Class 2

System, Test, C-Reactive Protein, Rhodamine

Clearances 1

Regulation 21 CFR 866.5270

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DCJ Class 1

Beta-Globulin, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5160

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DDD Class 2

Transferrin, Rhodamine, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5880

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DDY Class 2

Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5620

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DEF Class 1

Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5425

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DEP Class 2

Lambda, Peroxidase, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5550

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DET Class 1

Lactic Dehydrogenase, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5560

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DFB Class 2

Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5130

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DFF Class 2

Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5080

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DFG Class 2

Lambda, Rhodamine, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5550

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DFS Class 2

Igm, Fitc, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5550

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DGB Class 1

Seminal Fluid, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5800

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DGH Class 2

Igd, Peroxidase, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5510

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DGJ Class 1

Colostrum, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5230

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DGQ Class 1

Whole Blood Plasma, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5700

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DGX Class 1

Ng1m(A), Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5065

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DHF Class 1

D/Km-1, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5065

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DHI Class 1

Ng3m(Bo), Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5065

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DHY Class 1

Ng4m(A), Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5065

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JZP Class 1

Plates, Ouchterlony Agar

Clearances 1

Regulation 21 CFR 866.4600

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JZX Class 1

Equipment, Rocket Immunoelectrophoresis

Clearances 1

Regulation 21 CFR 866.4830

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KHT Class 1

Fraction V, Antigen, Antiserum, Control

Clearances 1

Regulation 21 CFR 866.5370

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KTP Class 2

Complement C3b Activator Immunoassay Reagents

Clearances 1

Regulation 21 CFR 866.5260

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LOQ Class 2

Device, General Purpose, Hematology

Clearances 1

Regulation 21 CFR 866.6010

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MVE Class 2

Biosensor, Immunoassay, Myoglobin

Clearances 1

Regulation 21 CFR 866.5680

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MVS Class 2

Kit, Typing, Hla-Dqb

Clearances 1

Regulation 21 CFR 866.5660

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NJF Class 2

Antibodies, Anti-Actin, Anti-Smooth Muscle

Clearances 1

Regulation 21 CFR 866.5120

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NSF Class 2

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Clearances 1

Regulation 21 CFR 866.6030

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NTW Class 2

System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

Clearances 1

Regulation 21 CFR 866.4070

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NTY Class 2

System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

Clearances 1

Regulation 21 CFR 866.6010

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NUM Class 2

Autoantibodies, Nuclear Body Protein, Sp100

Clearances 1

Regulation 21 CFR 866.5090

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OAU Class 2

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Clearances 1

Regulation 21 CFR 866.6030

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OCN Class 2

Insulin Autoantibody Kit

Clearances 1

Regulation 21 CFR 866.5660

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OKM Class 2

Antibodies, Outer-Membrane Proteins

Clearances 1

Regulation 21 CFR 866.5785

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OPN Class 2

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Clearances 1

Regulation 21 CFR 866.5660

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OPX Class 2

Immunoglobulin A Kappa Heavy & Light Chain Combined

Clearances 1

Regulation 21 CFR 866.5510

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OQZ Class 2

Anti-Mutated Citrullinated Vimentin Igg

Clearances 1

Regulation 21 CFR 866.5775

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OSK Class 2

Anti-Glutamate Receptor (Type Nmda) Ifa

Clearances 1

Regulation 21 CFR 866.5660

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OWK Class 2

Early Growth Response 1 (Egr) Fish Probe Kit

Clearances 1

Regulation 21 CFR 866.6040

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OWM Class 2

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

Clearances 1

Regulation 21 CFR 866.6040

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OXP Class 2

Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

Clearances 1

Regulation 21 CFR 866.6010

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OYL Class 2

Tryptase Assay System

Clearances 1

Regulation 21 CFR 866.5760

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OZF Class 2

Tissue Rna Preservative For Collection, Storage, And Transportation

Clearances 1

Regulation 21 CFR 866.4070

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PAF Class 2

Voltage Gated Calcium Channel (Vgcc) Antibody Assay

Clearances 1

Regulation 21 CFR 866.5660

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PFF Class 2

High Throughput Dna Sequence Analyzer

Clearances 1

Regulation 21 CFR 862.2265

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PFR Class 2

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

Clearances 1

Regulation 21 CFR 866.5900

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PFS Class 2

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Clearances 1

Regulation 21 CFR 866.5900

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PFX Class 2

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

Clearances 1

Regulation 21 CFR 866.5920

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PJI Class 2

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

Clearances 1

Regulation 21 CFR 866.5930

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PNI Class 2

Aquaporin-4 Autoantibody

Clearances 1

Regulation 21 CFR 866.5665

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QTE Class 2

Thymidine Kinase Activity

Clearances 1

Regulation 21 CFR 866.6010

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QXS Class 2

Chromogranin A

Clearances 1

Regulation 21 CFR 866.6010

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SGG Class 2

Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

Clearances 1

Regulation 21 CFR 866.5510

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CZL Class 2

Iga, Peroxidase, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5510

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CZO Class 1

Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5890

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CZR Class 2

Hemopexin, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5490

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CZT Class 2

Hemopexin, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5490

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CZZ Class 2

Haptoglobin, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5460

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DAG Class 2

Complement C8, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5240

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DAI Class 2

Complement C1r, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5240

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DAJ Class 2

Free Secretory Component, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5380

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DAL Class 1

Fraction Iv-5, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5360

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DAM Class 2

Hemoglobin, Chain Specific, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5470

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DAW Class 1

Alpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5425

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DBC Class 1

Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5425

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DBH Class 1

Fc, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5530

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DBK Class 1

Fc, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5530

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DCO Class 1

Alpha-Globulin, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5400

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DCT Class 2

Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5210

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DCY Class 2

Ceruloplasmin, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5210

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DDH Class 1

Carbonic Anhydrase B, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5200

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DDJ Class 2

Thyroglobulin, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5870

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DDK Class 1

Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5440

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DDL Class 2

Thyroglobulin, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5870

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DDN Class 1

Beta-2-Glycoprotein I, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5430

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DDO Class 2

Myoglobin, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5680

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DDT Class 2

Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5620

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DEA Class 2

Myoglobin, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5680

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DEC Class 1

Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5890

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DEJ Class 1

Alpha-2-Glycoproteins, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5425

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DEK Class 2

Kappa, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5550

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DEZ Class 2

Igm, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5550

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DFJ Class 2

Albumin, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5040

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DFM Class 2

Ige, Ferritin, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5510

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DFO Class 2

Igg, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5510

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DFQ Class 1

Sperm, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5800

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DFX Class 1

Sperm, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5800

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DGA Class 1

Cohn Fraction Ii, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5220

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DGG Class 2

Igd, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5510

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DGI Class 1

Breast Milk, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5170

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DGL Class 2

Ige, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5510

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DGM Class 1

Breast Milk, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5170

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DGN Class 1

Breast Milk, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5170

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DGW Class 2

System, Test, Hypersensitivity Pneumonitis

Clearances 0

Regulation 21 CFR 866.5500

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DHQ Class 1

Ng3m(G), Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 866.5065

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JFQ Class 2

P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin

Clearances 0

Regulation 21 CFR 866.5210

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KTK Class 1

Reagent, Immunoassay, Carbonic Anhydrase B And C

Clearances 0

Regulation 21 CFR 866.5200

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KTM Class 2

C3-Indirect Immunofluorescent Solid Phase

Clearances 0

Regulation 21 CFR 866.5240

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MLH Class 2

Strip, Hama Igg, Elisa, In Vitro Test System

Clearances 0

Regulation 21 CFR 866.5510

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MUT Class 2

Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)

Clearances 0

Regulation 21 CFR 866.6010

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NHS Class 2

Assay, Genotype, Hiv Drug Resistance, In Vitro

Clearances 0

Regulation 21 CFR 866.3950

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NPH Class 2

Antigen, Cartilage Oligomeric Matrix Protein (Comp)

Clearances 0

Regulation 21 CFR 866.5775

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NRX Class 2

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Clearances 0

Regulation 21 CFR 866.5820

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NVA Class 2

Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma

Clearances 0

Regulation 21 CFR 866.6010

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OPY Class 2

Igal Heavy & Light Chain Combined

Clearances 0

Regulation 21 CFR 866.5510

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OYV Class 2

Inherited Nucleotide Repeat Disorder Dna Test

Clearances 0

Regulation 21 CFR 866.5970

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PCO Class 2

Immunoglobulin G Lambda Heavy And Light Chain Combined

Clearances 0

Regulation 21 CFR 866.5510

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PDE Class 2

Immunoglobulin M Kappa Heavy And Light Chain Combined

Clearances 0

Regulation 21 CFR 866.5510

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PDF Class 2

Immunoglobulin M Lambda Heavy And Light Chain Combined

Clearances 0

Regulation 21 CFR 866.5510

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PET Class 2

Anti-Ss-A Ro60 Autoantibodies

Clearances 0

Regulation 21 CFR 866.5100

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PHF Class 2

Zinc Transporter 8 Auto-Antibody

Clearances 0

Regulation 21 CFR 866.5670

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PIV Class 2

Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Clearances 0

Regulation 21 CFR 866.4750

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PKB Class 2

Autosomal Recessive Carrier Screening Gene Mutation Detection System

Clearances 0

Regulation 21 CFR 866.5940

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PUW Class 2

System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens

Clearances 0

Regulation 21 CFR 866.5750

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QSA Class 2

Circulating Tumor Cell (Ctc) Enrichment Device

Clearances 0

Regulation 21 CFR 866.6110

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QUE Class 2

Spinal Muscular Atrophy Newborn Screening Test System

Clearances 0

Regulation 21 CFR 866.5980

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QUK Class 2

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Clearances 0

Regulation 21 CFR 866.5960

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QYO Class 2

Hematopoietic Cell Enrichment Kit

Clearances 0

Regulation 21 CFR 866.6120

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SFC Class 2

Neurologic Disease Risk Assessment Molecular Test

Clearances 0

Regulation 21 CFR 866.5850

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SGW Class 2

Device To Detect Antibodies To Hepatitis D Virus

Clearances 0

Regulation 21 CFR 866.3176

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