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

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot (JBG) (7) Calibrator, Secondary (JIT) (2) Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative (JBL) (1)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516741521 Catalog Number : 203-A

Device Description : G-6-PDH Deficiency (50 Tests)

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : JBG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741552 Catalog Number : 345-A

Device Description : Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (20 Tests)

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : JBL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741651 Catalog Number : 400-10x10

Device Description : G-6-PDH Substrate 10x10

Device Class : 2

Duns Number: 988298840

Premarket Exempt : Yes

Product Code : JBG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741675 Catalog Number : 400-4-50

Device Description : Trizma Buffer Solution

Device Class : 2

Duns Number: 988298840

Premarket Exempt : Yes

Product Code : JBG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741682 Catalog Number : 400-5-100

Device Description : Mineral Oil

Device Class : 2

Duns Number: 988298840

Premarket Exempt : Yes

Product Code : JBG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741699 Catalog Number : 400-5-1000

Device Description : Mineral Oil

Device Class : 2

Duns Number: 988298840

Premarket Exempt : Yes

Product Code : JBG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741705 Catalog Number : 400K-100-5X20

Device Description : G-6-PDH Deficiency 5 x 20 Kit

Device Class : 2

Duns Number: 988298840

Premarket Exempt : Yes

Product Code : JBG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741712 Catalog Number : 400K-100X

Device Description : G-6-PDH Deficiency 100X Kit

Device Class : 2

Duns Number: 988298840

Premarket Exempt : Yes

Product Code : JBG

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741859 Catalog Number : 450-100

Device Description : Bile Acid Calibrator 100 umol/l (5 mL)

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516741866 Catalog Number : 450-11

Device Description : Bile Acid Calibrator Set (5 x 5 mL)

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

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