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 Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (MXJ) (2) Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (MYF) (2) Test, Antigen, Nuclear, Epstein-Barr Virus (LLM) (2) Antisera, Cf, Herpesvirus Hominis 1,2 (GQO) (1) Epstein-Barr Virus, Other (LSE) (1) Antiserum, Cf, Varicella-Zoster (GQX) (1) Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster (LFY) (1)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516743471 Catalog Number : 2325450

Device Description : Captia™ Herpes Simplex Virus 1 (HSV 1) IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : MXJ

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743488 Catalog Number : 2325460

Device Description : Captia™ Herpes Simplex Virus 1 (HSV 1) IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : MXJ

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743495 Catalog Number : 2325500

Device Description : Captia™ Herpes Simplex Virus 2 (HSV 2) IgG

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : GQO

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743501 Catalog Number : 2325550

Device Description : Captia™ Herpes Simplex Virus 2 (HSV 2) IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : MYF

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743518 Catalog Number : 2325560

Device Description : Captia™ Herpes Simplex Virus 2 (HSV 2) IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : MYF

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743525 Catalog Number : 2325600

Device Description : Captia™ Varicella-Zoster Virus (VZV) IgG

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : GQX

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743532 Catalog Number : 2325650

Device Description : Captia™ Varicella-Zoster Virus (VZV) IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LFY

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743556 Catalog Number : 2325760

Device Description : Captia™ EBV VCA IgM

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LSE

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743570 Catalog Number : 2325800

Device Description : Captia™ EBNA-1 IgG

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LLM

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743587 Catalog Number : 2325860

Device Description : Captia™ EBNA-1 IgM

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LLM

Prescription Use : No

Device Count : 1

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