TRINITY BIOTECH PUBLIC LIMITED COMPANY

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

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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) (6) Antisera, Conjugated Fluorescent, Cytomegalovirus (LIN) (3) Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative (JBL) (1)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516745680 Catalog Number : 345-B

Device Description : Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (50 Tests)

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : JBL

Prescription Use : No

Device Count : 1

Bartels® - 05391516745826 Catalog Number : B1029-44

Device Description : Bartels® HSV Type Specific Fluorescent Monoclonal Antibody Test

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Bartels® - 05391516745864 Catalog Number : B1029-44C

Device Description : Bartels® HSV Type 1 and Type 2 Antigen Control Slides

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Bartels® - 05391516745871 Catalog Number : B1029-81

Device Description : Bartels® CMV Fluorescent Antibody Test

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : LIN

Prescription Use : No

Device Count : 1

Bartels® - 05391516745888 Catalog Number : B1029-81B

Device Description : Bartels® Cytomegalovirus Antigen Control Slides

Device Class :

Duns Number: 988298840

Premarket Exempt : No

Product Code : LIN

Prescription Use : No

Device Count : 10

Bartels® - 05391516745901 Catalog Number : B1029-91

Device Description : Bartels® CMV Immediate Early Antigen Kit

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : LIN

Prescription Use : No

Device Count : 1

Bartels® - 05391516745918 Catalog Number : B1029-47

Device Description : Bartels® HSV Fluorescent Monoclonal Antibody Test

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Bartels® - 05391516745925 Catalog Number : B1029-47C

Device Description : Bartels® Anti-HSV mouse monoclonal FITC conjugate

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Bartels® - 05391516745932 Catalog Number : B1029-48

Device Description : Bartels® HSV Fluorescent Monoclonal Antibody Test

Device Class : 2

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Bartels® - 05391516745949 Catalog Number : B1029-47B

Device Description : Bartels® Herpes Simplex Virus Antigen Control Slides

Device Class :

Duns Number: 988298840

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 10

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