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

Extractable Antinuclear Antibody, Antigen And Control (LLL) (5) Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM) (3) Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (DBM) (1) Immunochemical, Thyroglobulin Autoantibody (JNL) (1)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516743747 Catalog Number : 2337070

Device Description : Captia™ SSA (Ro)

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743754 Catalog Number : 2337170

Device Description : Captia™ SSB (La)

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743761 Catalog Number : 2337270

Device Description : Captia™ Smith (Sm)

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743778 Catalog Number : 2337370

Device Description : Captia™ Sm/RNP

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743785 Catalog Number : 2337470

Device Description : Captia™ Scl-70

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743792 Catalog Number : 2337570

Device Description : Captia™ Jo-1

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743808 Catalog Number : 2337870

Device Description : Captia™ Thyroglobulin

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : JNL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743822 Catalog Number : 2338170

Device Description : Captia™ ENA Profile

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743839 Catalog Number : 2338370

Device Description : Captia™ Mitochondria

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : DBM

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743860 Catalog Number : 2338570

Device Description : Captia™ ENA Combined Screen

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

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