FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516749923
Brand
Trinity Biotech
Company
PRIMUS CORPORATION
Model
Premier Hb9210 HbA1c Analytical Column (2500)
Catalog number
09-06-2500
Device description
Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (2500)
Published
2024-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112015000PREMIER HB9210 HBA1C ANALYZERPrimus Corporation Dba Trinity Biotech2011-11-22LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516749923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516749923053915167499235391516749923

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790074793
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516749893Trinity BiotechPremier Buffer A Plus Reagent - 940 mL 01-03-00582024-04-12
05391516749909Trinity BiotechPremier Buffer A Plus Reagent - 3.8 L 01-03-00552024-04-12
05391516749916Trinity BiotechPremier Hb9210 HbA1c Analytical Column (1500)09-06-15002024-04-12
05391516749930Trinity Biotech Premier Hb9210 HbA1c Analytical Column (4000)09-06-40002024-04-12
05391516744379Trinity BiotechHbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 01-04-00152016-09-06
05391516744751Trinity BiotechPremier Hb9210 HbA1c Analyzer - 1 each09-00-00012016-09-06
05391516744768Trinity BiotechPremier Buffer A Reagent - 940mL01-03-00952016-09-06
05391516744775Trinity BiotechPremier Buffer B Reagent - 940mL01-03-00962016-09-06
05391516744782Trinity BiotechPremier Diluent Reagent - 3.8L01-03-00972016-09-06
05391516744799Trinity BiotechPremier Wash Reagent - 940mL01-03-00982016-09-06
05391516744812Trinity BiotechHbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) -01-04-00182016-09-06
05391516748056Trinity BiotechPremier Hb9210 HbA1c Analytical Column (1000)09-06-00462016-09-06
05391516748063Trinity BiotechPremier Hb9210 HbA1c Analytical Column (500)09-06-00502016-09-06
05391516748070Trinity BiotechHbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) -01-04-00222016-09-06
05391516748087Trinity BiotechHbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 01-04-00202016-09-06
05391516748094Trinity BiotechPremier Buffer A Reagent - 3.8L01-03-00802016-09-06
05391516748100Trinity BiotechPremier Buffer B Reagent - 3.8L01-03-00812016-09-06
05391516748117Trinity BiotechPremier Sample Diluent Reagent - 940mL01-03-01012016-09-06
05391516748124Trinity BiotechPremier Affinity A1c 500 - 1 kit09-03-00082016-09-06
05391516748131Trinity BiotechPremier Affinity A1c 1000 - 1 kit09-03-00102016-09-06

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Primary DI, Brand, Company table
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00860004423492QvinQurasense, Inc.LCP2026-05-08
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONLCP2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONLCP2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONLCP2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONLCP2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONLCP2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONLCP2026-01-05
04713106028187URIGHT Hemoglobin A1c AnalyzerTAIDOC TECHNOLOGY CORPORATIONLCP2025-03-26
05391516749893Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749909Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749916Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749930Trinity Biotech PRIMUS CORPORATIONLCP2024-04-12
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00304040178430Henry ScheinHENRY SCHEIN, INC.LCP2024-01-12
10673486001792Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent SetTECO DIAGNOSTICSLCP2023-11-15
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00381933080018A1CNow Self Check, 8ct.POLYMER TECHNOLOGY SYSTEMS, INC.LCP2023-10-25
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03661540304286Direct A1c Control KitELITECHGROUP INC.LCP2023-10-01
03661540304293Direct A1c Calibrator KitELITECHGROUP INC.LCP2023-10-01
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