FDA.reportPublic FDA data

AU

Primary DI
15099590010447
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6147
Device description
CRP
Published
2016-09-24
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
DCNSystem, Test, C-Reactive Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DCNSystem, Test, C-Reactive ProteinImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954537000OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.1996-02-14DCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590010447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001044715099590010447

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of C-reactive protein (CRP) 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
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414610887Atellica CH Revised C-Reactive Protein (RCRP)Siemens Healthcare Diagnostics Inc.DCN2024-02-02
00630414305127Atellica CH Revised C-Reactive Protein (RCRP)Siemens Healthcare Diagnostics Inc.DCN2024-02-02
00895160002694Nano-Check TM CRP plus TestNANO-DITECH CORPORATIONDCN2022-03-15
10895160002691Nano-Check TM CRP plus TestNANO-DITECH CORPORATIONDCN2022-03-15
00894175000312AccuDiag™Diagnostic Automation, Inc.DCN2021-08-26
00895160002670Fluoro-CheckTM CRP Test NANO-DITECH CORPORATIONDCN2020-09-22
10895160002677Fluoro-CheckTM CRP Test NANO-DITECH CORPORATIONDCN2020-09-22
07613336121191Tina-quant C-Reactive Protein IVRoche Diagnostics GmbHDCN2020-06-16
04015630946839Tina-quant CReactive Protein IVRoche Diagnostics GmbHDCN2020-05-13
04015630946846Tina-quant CReactive Protein IVRoche Diagnostics GmbHDCN2020-05-13
04015630946853Tina-quant CReactive Protein IVRoche Diagnostics GmbHDCN2020-05-13
07613336121184C-Reactive Protein Gen.3Roche Diagnostics GmbHDCN2020-03-05
05051700020152Optilite High Sensitivity C-Reactive Protein KitTHE BINDING SITE GROUP LIMITEDDCN2019-03-04
05051700018449Optilite C-Reactive Protein ReagentTHE BINDING SITE GROUP LIMITEDDCN2018-05-31
05051700020084Optilite C-Reactive Protein CalibratorTHE BINDING SITE GROUP LIMITEDDCN2018-05-31
05051700020091Optilite C-Reactive Protein ControlsTHE BINDING SITE GROUP LIMITEDDCN2018-05-31
00630414596198Atellica CH CRP_2Siemens Healthcare Diagnostics Inc.DCN2017-12-27
00006136471271Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.DCN2017-10-27
00006136471288Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.DCN2017-10-27
08806133010099ichroma ReaderBoditech Med Inc.DCN2017-10-26
05051700018456C-Reactive Protein Kit for SPAPLUSTHE BINDING SITE GROUP LIMITEDDCN2017-09-27
08806679001520ichroma™ CRPBoditech Med Inc.DCN2016-12-20
10859035006016IMMUNEX CRP® ALERE NORTH AMERICA, LLCDCN2016-09-24
00842768006081Dimension Vista® C-Reactive Protein Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDCN2016-09-24
00842768011078RapiTex® CRPSiemens Healthcare Diagnostics Products GmbHDCN2016-09-24
00842768011085RapiTex® CRPSiemens Healthcare Diagnostics Products GmbHDCN2016-09-24
00842768012778RapiTex® CRPSiemens Healthcare Diagnostics Products GmbHDCN2016-09-24
00842768014130Dimension® Flex® reagent cartridge RCRPSiemens Healthcare Diagnostics Inc.DCN2016-09-24
00630414552118ADVIA® Chemistry CRP_2 ReagentsSiemens Healthcare Diagnostics Inc.DCN2016-09-24
00613647001271Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.DCN2016-09-24