FDA.reportPublic FDA data

Atellica CH Revised C-Reactive Protein (RCRP)

Primary DI
00630414305127
Brand
Atellica CH Revised C-Reactive Protein (RCRP)
Company
Siemens Healthcare Diagnostics Inc.
Model
11537223
Catalog number
11537223
Device description
Atellica CH C-Reactive Protein (RCRP) Reagent
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K221119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221119000RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.2023-03-17DCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414610887PrimaryGS10
00630414305127Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414610887006304146108876304146108870630414610887
00630414305127006304143051276304143051270630414305127

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 qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a nephelometry/turbidimetry method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
4
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

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
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
00630414552118ADVIA® Chemistry CRP_2 ReagentsSiemens Healthcare Diagnostics Inc.DCN2016-09-24
00613647001271Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.DCN2016-09-24