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

Assay, Glycosylated Hemoglobin (LCP) (4) Abnormal Hemoglobin Quantitation (GKA) (3) Control, Hemoglobin, Abnormal (JCM) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

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Trinity Biotech - 05391516748162 Catalog Number : 01-04-0080

Device Description : Hemoglobin A1c assay, Ultra2 Affinity A1c 3000

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748179 Catalog Number : 03-01-0053

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 - 05391516748186 Catalog Number : 01-04-0078

Device Description : Hemoglobin variants assay, Ultra2 Resolution 500 kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748193 Catalog Number : 01-03-0019

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

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748216 Catalog Number : 03-06-0011

Device Description : Hemoglobin A1c assay, Tri-stat Liquid Controls Kit

Device Class : 1

Duns Number: 790074793

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748223 Catalog Number : 03-06-0010

Device Description : Hemoglobin A1c assay, Tri-stat Reagent Kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748315 Catalog Number : 01-04-0044

Device Description : Hemoglobin variants assay, Premier Resolution A2+F Calibrator Kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : JCM

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748322 Catalog Number : 01-04-0045

Device Description : Hemoglobin variants assay, Premier Resolution A2+F Control Material Kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : JCM

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748605 Catalog Number : 01-03-0064

Device Description : Hemoglobin A1c assay, PDQ1 Reagent - 940mL

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748612 Catalog Number : 01-03-0065

Device Description : Hemoglobin A1c assay, PDQ 2 Reagent - 940mL

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

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