TRINITY BIOTECH PUBLIC LIMITED COMPANY

Address:2823 Girts Rd,Jamestown,NY,14701,US

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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

Antisera, Fluorescent, Herpesvirus Hominis 1,2 (GQL) (2) Test, Hiv Detection (MZF) (2) Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 (GQN) (1) Radioassay, Angiotensin Converting Enzyme (KQN) (1) System, Test, Oxalate (LPW) (1) Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot (JBG) (1) Antigen, Cf (Including Cf Control), Rubella (GON) (1)

Premarket Exempt

No Yes

Clear

MicroTrak® - 05391516746007 Catalog Number : 8H219UL

Device Description : MicroTrak® HSV-1/HSV-2 Culture Identification/Typing Test

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : GON

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746014 Catalog Number : 305-10

Device Description : ACE Reagent

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : KQN

Prescription Use : No

Device Count : 1

MicroTrak® - 05391516746038 Catalog Number : 8H349UL

Device Description : MicroTrak® HSV-1/HSV-2 Direct Specimen Identification/Typing Test

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Uni-Gold™ - 05391516746106 Catalog Number : 1206506

Device Description : Uni-Gold™ Recombigen® HIV-1/2

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

Uni-Gold™ - 05391516746113 Catalog Number : 1206530

Device Description : Uni-Gold™ Recombigen® HIV Controls

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

MicroTrak® - 05391516746144 Catalog Number : 8H399UL

Device Description : MicroTrak® HSV-1/HSV-2 Direct Specimen Identification/Typing Test Control Slide Pack

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQN

Prescription Use : No

Device Count : 1

MicroTrak® - 05391516748643 Catalog Number : 8H329UL

Device Description : MicroTrak® HSV 1 /HSV 2 Direct Specimen - Collection Kit

Device Class :

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516749411 Catalog Number : 400-5x10

Device Description : G-6-PDH Substrate 5x10

Device Class : 2

Duns Number: 988298840

Premarket Exempt : Yes

Product Code : JBG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516749640 Catalog Number : 591-4-1000

Device Description : Oxalate Sample Diluent

Device Class : 1

Duns Number: 988298840

Premarket Exempt : No

Product Code : LPW

Prescription Use : No

Device Count : 1

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