PRIMUS CORPORATION

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

Abnormal Hemoglobin Quantitation (GKA) (6) Assay, Glycosylated Hemoglobin (LCP) (4)

Premarket Exempt

Clear

Trinity Biotech - 05391516744102 Catalog Number : 03-01-0045

Device Description : Hemoglobin variants assay, Ultra2 Genesys Variants Analyzer

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744119 Catalog Number : 03-01-0047

Device Description : Hemoglobin variants assay, Ultra2 Resolution Variants Analyzer

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744126 Catalog Number : 03-01-0048

Device Description : Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (220V)

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744164 Catalog Number : 01-03-0011

Device Description : Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 940mL

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744171 Catalog Number : 01-03-0012

Device Description : Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744195 Catalog Number : 01-03-0020

Device Description : Hemoglobin variants assay, Genesys 1 Reagent - 3.8L

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744201 Catalog Number : 01-03-0022

Device Description : Hemoglobin variants assay, Genesys 2 Reagent - 3.8L

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744218 Catalog Number : 01-03-0035

Device Description : Hemoglobin A1c assay, System Wash Reagent - 940mL

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744232 Catalog Number : 01-03-0040

Device Description : Hemoglobin variants assay, Mobile Phase 1 Reagent - 3.8L

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744249 Catalog Number : 01-03-0041

Device Description : Hemoglobin variants assay, Mobile Phase 2 Reagent - 3.8L

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

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