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, Rubella (LFX) (3) Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (3) Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (LFZ) (2) Antisera, Cf, Herpesvirus Hominis 1,2 (GQO) (1) Antiserum, Cf, Cytomegalovirus (GQI) (1)

Premarket Exempt

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Clear

Trinity Biotech - 05391516743372 Catalog Number : 2325100

Device Description : Captia™ Toxoplasma gondii IgG

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743389 Catalog Number : 2325150

Device Description : Captia™ Toxoplasma gondii IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743396 Catalog Number : 2325160

Device Description : Captia™ Toxoplasma gondii IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743402 Catalog Number : 2325200

Device Description : Captia™ Cytomegalovirus (CMV) IgG

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : GQI

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743419 Catalog Number : 2325250

Device Description : Captia™ Cytomegalovirus IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LFZ

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743426 Catalog Number : 2325260

Device Description : Captia™ Cytomegalovirus IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LFZ

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743433 Catalog Number : 2325300

Device Description : Captia™ Rubella IgG

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743440 Catalog Number : 2325350

Device Description : Captia™ Rubella IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743457 Catalog Number : 2325360

Device Description : Captia™ Rubella IgM

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743464 Catalog Number : 2325400

Device Description : Captia™ Herpes Simplex Virus 1 (HSV1) ) IgG

Device Class : 2

Duns Number: 623214079

Premarket Exempt : No

Product Code : GQO

Prescription Use : No

Device Count : 1

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