CLARK LABORATORIES, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Linked Immunoabsorbent Assay, Mumps Virus (LJY) (3) Enzyme Linked Immunoabsorbent Assay, Rubeola Igm (PCL) (2) Helicobacter Pylori (LYR) (2) Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control (LRM) (1) Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (LGC) (1) Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (LJB) (1)

Premarket Exempt

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Clear

Trinity Biotech - 05391516743600 Catalog Number : 2325900

Device Description : Captia™ Mumps IgG

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LJY

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743617 Catalog Number : 2325950

Device Description : Captia™ Mumps IgM

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LJY

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743624 Catalog Number : 2325960

Device Description : Captia™ Mumps IgM

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LJY

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743631 Catalog Number : 2326000

Device Description : Captia™ Measles IgG

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LJB

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743648 Catalog Number : 2326050

Device Description : Captia™ Measles IgM

Device Class : 1

Duns Number: 623214079

Premarket Exempt : Yes

Product Code : PCL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743655 Catalog Number : 2326060

Device Description : Captia™ Measles IgM

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : PCL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743679 Catalog Number : 2346400

Device Description : Captia™ H. pylori IgG

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LYR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743686 Catalog Number : 2326430

Device Description : Captia™ H. pylori IgA

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LYR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743709 Catalog Number : 2326650

Device Description : Captia™ Herpes Simplex Virus (HSV) Combined IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LGC

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743723 Catalog Number : 2327670

Device Description : Captia™ dsDNA

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LRM

Prescription Use : No

Device Count : 1

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