CLARK LABORATORIES, INC.

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

Whole Blood Hemoglobin Determination (KHG) (3) Epstein-Barr Virus, Other (LSE) (2) Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (MXJ) (1) Calibrator, Primary (JIS) (1) Lipase-Esterase, Enzymatic, Photometric, Lipase (CHI) (1) Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (MYF) (1) Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (LJZ) (1)

Premarket Exempt

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Clear

Trinity Biotech - 05391516741545 Catalog Number : 30550

Device Description : ACE Calibrator

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516742276 Catalog Number : 805A

Device Description : LIPASE-PS™

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : CHI

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743136 Catalog Number : G5029

Device Description : G6PDH Control, Intermediate

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743143 Catalog Number : G5888

Device Description : G6PDH Control, Deficient

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743150 Catalog Number : G6888

Device Description : G6PDH Control, Normal

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : KHG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743310 Catalog Number : 2323800

Device Description : Captia™ HSV 1 Type Specific IgG

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : MXJ

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743327 Catalog Number : 2323900

Device Description : Captia™ HSV 2 Type Specific IgG

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : MYF

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743334 Catalog Number : 2324700

Device Description : Captia™ EBV VCA P-18 IgG

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LSE

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743358 Catalog Number : 2324860

Device Description : Captia™ Mycoplasma IgM

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LJZ

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743365 Catalog Number : 2325000

Device Description : Captia™ EBV EA-D IgG

Device Class : 1

Duns Number: 623214079

Premarket Exempt : No

Product Code : LSE

Prescription Use : No

Device Count : 1

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