FDA.reportPublic FDA data

ADVIA® Chemistry CRP_2 Reagents

Primary DI
00630414552118
Brand
ADVIA® Chemistry CRP_2 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10283129
Catalog number
6522059
Device description
CRP - ADVIA Chem. - RGT - 4x250 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K072658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072658000ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORSSiemens Medical Solutions Diagnostics2008-04-01DCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414552118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414552118006304145521186304145521180630414552118

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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
15099590010447AUBeckman Coulter, Inc.DCN2016-09-24
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
00613647001271Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.DCN2016-09-24