PRIMUS CORPORATION

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

Assay, Glycosylated Hemoglobin (LCP) (3)

Premarket Exempt

Clear

Trinity Biotech - 05391516748629 Catalog Number : 01-03-0066

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

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748636 Catalog Number : 01-03-0067

Device Description : Hemoglobin A1c assay, PDQ Wash Reagent

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516749473 Catalog Number : 03-06-0002

Device Description : Tri-stat 2 Analyzer

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

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