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) (8) Abnormal Hemoglobin Quantitation (GKA) (1) Mixture, Hematology Quality Control (JPK) (1)

Premarket Exempt

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Trinity Biotech - 05391516744539 Catalog Number : 01-05-0017

Device Description : Hemoglobin variants assay, Genesys Analytical Column

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744546 Catalog Number : 01-12-0001

Device Description : Hemoglobin A1c assay, Enzyme Cleaner Tube

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744553 Catalog Number : 03-02-0079

Device Description : Hemoglobin A1c assay, Affinity Analytical Column

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744751 Catalog Number : 09-00-0001

Device Description : Hemoglobin A1c assay, Premier Hb9210 HbA1c Analyzer

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744768 Catalog Number : 01-03-0095

Device Description : Hemoglobin A1c assay, Premier Buffer A Reagent - 940mL

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744775 Catalog Number : 01-03-0096

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

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744782 Catalog Number : 01-03-0097

Device Description : Hemoglobin A1c assay, Premier Diluent Reagent - 3.8L

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744799 Catalog Number : 01-03-0098

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

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516744812 Catalog Number : 01-04-0018

Device Description : Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748056 Catalog Number : 09-06-0046

Device Description : Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (1000)

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

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