FDA.reportPublic FDA data

Tina-quant Hemoglobin A1cDx Gen.3

Primary DI
04015630942787
Brand
Tina-quant Hemoglobin A1cDx Gen.3
Company
Roche Diagnostics GmbH
Model
07559674190
Catalog number
07559674190
Published
2016-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PDJHemoglobin A1c test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDJHemoglobin A1c Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160571000cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayRoche Diagnostics Operations (Rdo)2016-12-19PDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630942787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630942787040156309427874015630942787

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740208622ARCHITECTAbbott GmbHPDJ2026-05-15
00380740208639AlinityAbbott GmbHPDJ2026-05-15
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONPDJ2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONPDJ2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONPDJ2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONPDJ2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONPDJ2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONPDJ2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONPDJ2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONPDJ2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONPDJ2026-01-05
06935784430016BioHermes Automated Glycohemoglobin AnalyzerWuxi Biohermes Bio & Medical Technology Co.,Ltd.PDJ2022-01-04
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00630414002859ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
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00630414002880ADVIA Chemistry Enzymatic hemoglobin A1c PretreatmentSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
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14987486015090ELUENT 80AARKRAY USA, INC.PDJ2018-02-08
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