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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

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
07613336120927Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07613336157824Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07070060014555Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2019-05-31
00380740135591AlinityAbbott GmbHPDJ2019-04-08
00630414220505Atellica CH A1c_ESiemens Healthcare Diagnostics Inc.PDJ2019-03-14
15099590012120AU BECKMAN COULTER IRELAND INC.PDJ2019-02-13
00630414006666Dimension Vista System Flex reagent cartridge A1C KITSiemens Healthcare Diagnostics Inc.PDJ2019-02-12
00630414006659Dimension Clinical Chemistry System A1C KitSiemens Healthcare Diagnostics Inc.PDJ2018-12-06
07070060012889Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2018-11-01
00628063401147HbA1c AssaySekisui Diagnostics, LLCPDJ2018-09-24
00630414002859ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
00630414002866ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
00630414002880ADVIA Chemistry Enzymatic hemoglobin A1c PretreatmentSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
04987486015093ELUENT 80AArkray USA, Inc.PDJ2018-02-08
04987486015109ELUENT 80BArkray USA, Inc.PDJ2018-02-08
04987486015116ELUENT 80CVArkray USA, Inc.PDJ2018-02-08
14987486015090ELUENT 80AARKRAY USA, INC.PDJ2018-02-08
14987486015106ELUENT 80BARKRAY USA, INC.PDJ2018-02-08