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) Mixture, Hematology Quality Control (JPK) (2)

Premarket Exempt

Clear

Trinity Biotech - 05391516748063 Catalog Number : 09-06-0050

Device Description : Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (500)

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748070 Catalog Number : 01-04-0022

Device Description : Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 500uL (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 - 05391516748087 Catalog Number : 01-04-0020

Device Description : Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748094 Catalog Number : 01-03-0080

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

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748100 Catalog Number : 01-03-0081

Device Description : Hemoglobin A1c assay, Premier 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 - 05391516748117 Catalog Number : 01-03-0101

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

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748124 Catalog Number : 09-03-0008

Device Description : Hemoglobin A1c assay, Premier Affinity A1c 500 - 1 kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748131 Catalog Number : 09-03-0010

Device Description : Hemoglobin A1c assay, Premier Affinity A1c 1000 - 1 kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748148 Catalog Number : 09-03-0007

Device Description : Hemoglobin A1c assay, Premier Affinity A1c 3000 - 1 kit

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Trinity Biotech - 05391516748155 Catalog Number : 03-01-0052

Device Description : Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (110V)

Device Class : 2

Duns Number: 790074793

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

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