Pathology Device Classification Codes

FMH Class 1

Container, Specimen, Sterile

Clearances 23

Regulation 21 CFR 864.3250

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PSY Class 2

Whole Slide Imaging System

Clearances 22

Regulation 21 CFR 864.3700

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KPA Class 1

Slide Stainer, Automated

Clearances 21

Regulation 21 CFR 864.3800

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PPM Class 1

General Purpose Reagent

Clearances 16

Regulation 21 CFR 864.4010

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IFP Class 1

Formalin, Neutral Buffered

Clearances 15

Regulation 21 CFR 864.4010

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KEM Class 1

Agent, Clearing

Clearances 15

Regulation 21 CFR 864.4010

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QKQ Class 2

Digital Pathology Image Viewing And Management Software

Clearances 15

Regulation 21 CFR 864.3700

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IEO Class 1

Processor, Tissue, Automated

Clearances 12

Regulation 21 CFR 864.3875

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KDT Class 1

Container, Specimen Mailer And Storage, Sterile

Clearances 12

Regulation 21 CFR 864.3250

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KEO Class 1

Formulations, Paraffin, All

Clearances 11

Regulation 21 CFR 864.4010

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IBJ Class 1

Light, Microscope

Clearances 9

Regulation 21 CFR 864.3600

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KDX Class 1

Solution, Decalcifier, Acid Containing

Clearances 8

Regulation 21 CFR 864.4010

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KEW Class 1

Slides, Microscope

Clearances 8

Regulation 21 CFR 864.3010

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LDZ Class 1

Fixative, Alcohol Containing

Clearances 8

Regulation 21 CFR 864.4010

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IGG Class 1

Formaldehyde (Formalin, Formol)

Clearances 7

Regulation 21 CFR 864.4010

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JCC Class 1

Ph Buffer

Clearances 7

Regulation 21 CFR 864.4010

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JCE Class 1

Solution, Isotonic

Clearances 7

Regulation 21 CFR 864.4010

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KEQ Class 1

Media, Mounting, Water Soluble

Clearances 7

Regulation 21 CFR 864.4010

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PZM Class 2

Next Generation Sequencing Based Tumor Profiling Test

Clearances 7

Regulation 21 CFR 866.6080

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IDL Class 1

Microtome, Accessories

Clearances 5

Regulation 21 CFR 864.3010

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IDO Class 1

Microtome, Rotary

Clearances 5

Regulation 21 CFR 864.3010

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IDZ Class 1

Cassettes, Tissue

Clearances 5

Regulation 21 CFR 864.3010

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KER Class 1

Container, Embedding

Clearances 5

Regulation 21 CFR 864.3010

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KET Class 1

Filters, Cell Collection, Tissue Processing

Clearances 5

Regulation 21 CFR 864.3010

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LEB Class 1

Mounting Media

Clearances 5

Regulation 21 CFR 864.4010

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KDW Class 1

Container, Specimen Mailer And Storage, Temperature Controlled, Sterile

Clearances 4

Regulation 21 CFR 864.3250

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LDW Class 1

Fixative, Acid Containing

Clearances 4

Regulation 21 CFR 864.4010

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LEA Class 1

Preservative, Cytological

Clearances 4

Regulation 21 CFR 864.4010

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IFB Class 1

Cytocentrifuge

Clearances 3

Regulation 21 CFR 864.3300

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IGM Class 1

Solution, Carnoy'S

Clearances 3

Regulation 21 CFR 864.4010

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KEP Class 1

Media, Mounting, Oil Soluble

Clearances 3

Regulation 21 CFR 864.4010

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KES Class 1

Coverslips, Microscope Slide

Clearances 3

Regulation 21 CFR 864.3010

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PZZ Class 2

Digital Pathology Display

Clearances 3

Regulation 21 CFR 864.3700

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QDS Class 2

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

Clearances 3

Regulation 21 CFR 866.4001

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IBG Class 1

Trypsin

Clearances 2

Regulation 21 CFR 864.4400

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IFH Class 1

Solution, Zenker'S

Clearances 2

Regulation 21 CFR 864.4010

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IFQ Class 1

Formulations, Mercuric Chloride For Tissue

Clearances 2

Regulation 21 CFR 864.4010

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IGC Class 1

Formalin-Saline

Clearances 2

Regulation 21 CFR 864.4010

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IGE Class 1

Solution, Formalin Ammonium Bromide

Clearances 2

Regulation 21 CFR 864.4010

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IGN Class 1

Fluid, Bouin'S

Clearances 2

Regulation 21 CFR 864.4010

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KEL Class 1

Adhesive, Albumin-Based

Clearances 2

Regulation 21 CFR 864.4010

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LIJ Class 1

Peroxidase Anti-Peroxidase Immunohistochemical Stain

Clearances 2

Regulation 21 CFR 864.4400

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SHW Class 2

Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

Clearances 2

Regulation 21 CFR 864.3755

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IBK Class 1

Microscope, Fluorescence/U.V.

Clearances 1

Regulation 21 CFR 864.3600

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IBM Class 1

Microscope, Phase Contrast

Clearances 1

Regulation 21 CFR 864.3600

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IDM Class 1

Microtome, Ultra

Clearances 1

Regulation 21 CFR 864.3010

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IDP Class 1

Microtome, Cryostat

Clearances 1

Regulation 21 CFR 864.3010

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IDS Class 1

Melting Pot, Paraffin

Clearances 1

Regulation 21 CFR 864.3010

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IDW Class 1

Dispensers, Paraffin

Clearances 1

Regulation 21 CFR 864.3010

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IEG Class 1

Table, Slide Warming

Clearances 1

Regulation 21 CFR 864.3010

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IER Class 1

Polyethylene Glycol (Carbowax)

Clearances 1

Regulation 21 CFR 864.4010

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IFI Class 1

Sprays, Synthetic, Smear

Clearances 1

Regulation 21 CFR 864.4010

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IFT Class 1

Glutaraldehyde

Clearances 1

Regulation 21 CFR 864.4010

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IFZ Class 1

Gelatin For Specimen Adhesion

Clearances 1

Regulation 21 CFR 864.4010

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IGB Class 1

Solution, Formalin-Sodium Acetate

Clearances 1

Regulation 21 CFR 864.4010

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IGF Class 1

Solution, Formalin-Alcohol-Acetic Acid

Clearances 1

Regulation 21 CFR 864.4010

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IJZ Class 1

Oil, Clearing

Clearances 1

Regulation 21 CFR 864.4010

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KEJ Class 1

Stages, Microscope

Clearances 1

Regulation 21 CFR 864.3600

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KEY Class 1

Stainer, Tissue, Automated

Clearances 1

Regulation 21 CFR 864.3800

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KIM Class 1

Device For Sealing Microsections

Clearances 1

Regulation 21 CFR 864.3400

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KIN Class 1

Slide Stainer, Contact Type

Clearances 1

Regulation 21 CFR 864.3800

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KIO Class 1

Slide Stainer, Immersion Type

Clearances 1

Regulation 21 CFR 864.3800

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KJG Class 1

Tube, Tissue Culture

Clearances 1

Regulation 21 CFR 864.3010

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LDX Class 1

Fixative, Metallic Containing

Clearances 1

Regulation 21 CFR 864.4010

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LDY Class 1

Fixative, Formalin-Containing

Clearances 1

Regulation 21 CFR 864.4010

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PRB Class 2

Cervical Intraepithelial Neoplasia (Cin) Test System

Clearances 1

Regulation 21 CFR 864.1865

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QDC Class 2

Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

Clearances 1

Regulation 21 CFR 866.6100

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QPN Class 2

Software Algorithm Device To Assist Users In Digital Pathology

Clearances 1

Regulation 21 CFR 864.3750

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HZI Class 1

Acid, Osmic

Clearances 0

Regulation 21 CFR 864.4010

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IAL Class 1

Iodine (Tincture)

Clearances 0

Regulation 21 CFR 864.4010

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IAM Class 1

Solution, Lugol'S

Clearances 0

Regulation 21 CFR 864.4010

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IAT Class 1

Syrup, Gum, Apathy'S

Clearances 0

Regulation 21 CFR 864.4010

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IAW Class 1

Collodion

Clearances 0

Regulation 21 CFR 864.4010

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IAY Class 1

Colchicine

Clearances 0

Regulation 21 CFR 864.4010

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IAZ Class 1

Heparin

Clearances 0

Regulation 21 CFR 864.4400

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IBA Class 1

Streptolysin O

Clearances 0

Regulation 21 CFR 864.4400

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IBB Class 1

Phytohemaglutinin M

Clearances 0

Regulation 21 CFR 864.4010

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IBC Class 1

Diastase

Clearances 0

Regulation 21 CFR 864.4400

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IBD Class 1

Hyaluronidase

Clearances 0

Regulation 21 CFR 864.4400

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IBE Class 1

Neuramininase (Sialidase)

Clearances 0

Regulation 21 CFR 864.4400

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IBF Class 1

Papain

Clearances 0

Regulation 21 CFR 864.4400

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IBL Class 1

Microscope, Inverted Stage, Tissue Culture

Clearances 0

Regulation 21 CFR 864.3600

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IDN Class 1

Microtome, Freezing Attachment

Clearances 0

Regulation 21 CFR 864.3010

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IDQ Class 1

Infiltrator

Clearances 0

Regulation 21 CFR 864.3010

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IDR Class 1

Ovens, Paraffin

Clearances 0

Regulation 21 CFR 864.3010

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IDT Class 1

Apparatus, Melting Point, Paraffin

Clearances 0

Regulation 21 CFR 864.3010

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IDX Class 1

Sieves, Tissue

Clearances 0

Regulation 21 CFR 864.3010

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IDY Class 1

Bath, Flotation, Tissue

Clearances 0

Regulation 21 CFR 864.3010

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IEH Class 1

Lamps, Slide Warming

Clearances 0

Regulation 21 CFR 864.3010

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IEX Class 1

Gelatin

Clearances 0

Regulation 21 CFR 864.4010

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IEZ Class 1

Celloidin

Clearances 0

Regulation 21 CFR 864.4010

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IFF Class 1

Solution, Decalcifier, Electrolytic

Clearances 0

Regulation 21 CFR 864.4010

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IFJ Class 1

Fixative, Richardson Glycol

Clearances 0

Regulation 21 CFR 864.4010

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IFL Class 1

Polyethylene Glycol Preservative

Clearances 0

Regulation 21 CFR 864.4010

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IFN Class 1

Solution, Orth'S

Clearances 0

Regulation 21 CFR 864.4010

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IFO Class 1

Solution, Newcomer'S

Clearances 0

Regulation 21 CFR 864.4010

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IFS Class 1

Solution, Helly

Clearances 0

Regulation 21 CFR 864.4010

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IFY Class 1

Gelatin-Formalin

Clearances 0

Regulation 21 CFR 864.4010

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IGD Class 1

Solution, Formol Calcium

Clearances 0

Regulation 21 CFR 864.4010

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IGK Class 1

Solution, Clarke'S

Clearances 0

Regulation 21 CFR 864.4010

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IHJ Class 1

Blender, Sputum

Clearances 0

Regulation 21 CFR 864.3010

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JCB Class 1

Detergent

Clearances 0

Regulation 21 CFR 864.4010

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KDY Class 1

Agent, Chelating For Decalcification

Clearances 0

Regulation 21 CFR 864.4010

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KDZ Class 1

Device, Decalcifier, Electrolytic

Clearances 0

Regulation 21 CFR 864.3010

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KEE Class 1

Osmium Tetroxide

Clearances 0

Regulation 21 CFR 864.4010

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KEF Class 1

Paraformaldehyde

Clearances 0

Regulation 21 CFR 864.4010

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KEG Class 1

Lamps, Microscope

Clearances 0

Regulation 21 CFR 864.3600

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KEH Class 1

Micrometers, Microscope

Clearances 0

Regulation 21 CFR 864.3600

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KEI Class 1

Condensers, Microscope

Clearances 0

Regulation 21 CFR 864.3600

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KFL Class 1

Microtome, Sliding

Clearances 0

Regulation 21 CFR 864.3010

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LEC Class 1

Grinder, Tissue

Clearances 0

Regulation 21 CFR 864.3010

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MJI Class 1

Specimen/Tissue, Identification Orientation

Clearances 0

Regulation 21 CFR 864.3010

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MPQ Class 1

Container, Specimen, Urine, Drugs Of Abuse, Over The Counter

Clearances 0

Regulation 21 CFR 864.3260

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MVD Class 2

System, Test, Her-2/Neu, Nucleic Acid Or Serum

Clearances 0

Regulation 21 CFR 864.1890

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MVU Class 1

Reagents, Specific, Analyte

Clearances 0

Regulation 21 CFR 864.4020

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MXT Class 1

Device, Accessory, Cooling Plate For Tissue Embedding Station

Clearances 0

Regulation 21 CFR 864.3010

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NNI Class 1

Container, Specimen, Non-Sterile

Clearances 0

Regulation 21 CFR 864.3250

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NNK Class 1

Container, Specimen Mailer And Storage, Non-Sterile

Clearances 0

Regulation 21 CFR 864.3250

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NNL Class 1

Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile

Clearances 0

Regulation 21 CFR 864.3250

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NYQ Class 2

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Clearances 0

Regulation 21 CFR 864.1890

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OHZ Class 1

Urine Transport Kit (Excludes Hiv Testing)

Clearances 0

Regulation 21 CFR 864.3250

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OIA Class 1

Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)

Clearances 0

Regulation 21 CFR 864.3250

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OIB Class 1

Blood And Urine Collection Kit (Excludes Hiv Testing)

Clearances 0

Regulation 21 CFR 864.3250

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OIE Class 1

Urine Collection Kit (Excludes Hiv Testing)

Clearances 0

Regulation 21 CFR 864.3250

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OWE Class 2

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Clearances 0

Regulation 21 CFR 864.1890

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PNK Class 2

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

Clearances 0

Regulation 21 CFR 864.1890

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PZF Class 2

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Clearances 0

Regulation 21 CFR 866.4001

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QVU Class 2

High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

Clearances 0

Regulation 21 CFR 866.6095

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QYV Class 2

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Clearances 0

Regulation 21 CFR 864.3900

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SBY Class 2

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

Clearances 0

Regulation 21 CFR 866.6085

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SFH Class 2

Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis

Clearances 0

Regulation 21 CFR 864.3755

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SIX Class 2

Digital Pathology Image Artifact Detection Software Device

Clearances 0

Regulation 21 CFR 864.3700

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