FDA.reportPublic FDA data

Tinaquant Soluble Transferrin Receptor

Primary DI
04015630918614
Brand
Tinaquant Soluble Transferrin Receptor
Company
Roche Diagnostics GmbH
Model
20763454122
Catalog number
20763454122
Published
2016-09-20
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
DDGTRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDGTransferrin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003064000TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323Roche Diagnostics Corp.2001-05-01DDG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630918614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630918614040156309186144015630918614

GMDN Terms#

Term, Definition table
TermDefinition
Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of transferrin or a transferrin isoform(s) [e.g., beta-2-transferrin, carbohydrate deficient transferrin] in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
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00380740171278AlinityABBOTT IRELANDDDG2021-03-26
00380740171285ARCHITECTABBOTT IRELANDDDG2021-03-26
00380740179021ARCHITECTABBOTT IRELANDDDG2021-03-26
04015630919444sTfR Control SetRoche Diagnostics GmbHDDG2021-02-08
00380740161439ARCHITECTAbbott GmbHDDG2020-11-06
00380740161446ARCHITECTAbbott GmbHDDG2020-11-06
07613336147924Tina-quant Soluble Transferrin ReceptorRoche Diagnostics GmbHDDG2020-10-29
03610230007419Yumizen C1200 TransferrinHORIBA ABX SASDDG2020-05-06
07613336121573Tina-quant Transferrin ver. 2Roche Diagnostics GmbHDDG2020-03-05
00380740135096AlinityAbbott GmbHDDG2019-06-27
00816870020341sTfR AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DDG2019-02-11
00816870020358sTfR AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DDG2019-02-11
00816870022024sTfR AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DDG2019-02-11
00816870022031sTfR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DDG2019-02-11
B1761250Antiserum to Human TransferrinKENT LABORATORIES INCDDG2016-09-24
05051700010788Human Transferrin BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDDG2016-09-24
05051700017640Optilite Transferrin KitTHE BINDING SITE GROUP LIMITEDDDG2016-09-24
05055273206494TFRANDOX LABORATORIES LIMITEDDDG2016-09-24
05055273206500TFRANDOX LABORATORIES LIMITEDDDG2016-09-24
00842768005244Dimension® Flex® reagent cartridge TRNFSiemens Healthcare Diagnostics Inc.DDG2016-09-24
00842768006258DImension Vista® Transferrin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768008054N Latex sTfRSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768008061N Supplementary Reagent LSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768009891N Antiserum to Human TransferrinSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768009907N Antiserum to Human TransferrinSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
04015630914395Tinaquant Soluble Transferrin ReceptorRoche Diagnostics GmbHDDG2016-09-20
04015630917419Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20
04015630917426Transferrin ver 2 Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20
04015630917440Transferrin ver 2 Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20