FDA.reportPublic FDA data

Synchron

Primary DI
15099590575069
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
467942
Catalog number
467942
Device description
Transferrin Reagent (TRFN 2 x 150)
Published
2016-08-24
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
K971958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971958000SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENTBeckman Instruments, Inc.1997-08-20DDG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590575069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959057506915099590575069

GMDN Terms#

Term, Definition table
TermDefinition
Transferrin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of transferrin in a clinical specimen, using a nephelometry/turbidimetry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000473AccuDiag™Diagnostic Automation, Inc.DDG2021-09-07
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