FDA.reportPublic FDA data

Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)

Primary DI
00630414611112
Brand
Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Company
Siemens Healthcare Diagnostics Inc.
Model
11537224
Catalog number
11537224
Device description
Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent
Published
2024-06-11
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
NQDCARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414611112PrimaryGS10
00630414305028Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414611112006304146111126304146111120630414611112
00630414305028006304143050286304143050280630414305028

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

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
2
Lot or batch
true
Expiration date on label
true

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
00630414305028Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics Inc.NQD2024-06-11
07613336121207Cardiac C-Reactive Protein (Latex) High SensitiveRoche Diagnostics GmbHNQD2020-03-05
00380740180331AlinityABBOTT LABORATORIESNQD2020-01-13
00380740181024AlinityABBOTT LABORATORIESNQD2020-01-13
00380740158491ARCHITECTABBOTT LABORATORIESNQD2018-12-28
00380740158507ARCHITECTABBOTT LABORATORIESNQD2018-12-28
00630414596174Atellica CH hsCRPSiemens Healthcare Diagnostics Inc.NQD2017-12-21
15099590010959AUBeckman Coulter, Inc.NQD2016-09-24
00842768006135Dimension Vista hsCRP Flex reagent cartridgeSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768007729CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768007736CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHNQD2016-09-24
00842768016028Dimension CardioPhase high sensitivity CRP Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.NQD2016-09-24
00630414552699ADVIA Chemistry CardioPhase High Sensitivity C-Reactive ProteinSiemens Healthcare Diagnostics Inc.NQD2016-09-24
00630414953144IMMULITE® Systems CRP CONTROL C-Reactive ProteinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414953670IMMULITE®/IMMULITE® 1000 Systems CRP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414953687IMMULITE® 2000 Systems CRP CRP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414961200IMMULITE® 2000 Systems hsC High Sensitivity CRPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
00630414963792IMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNQD2016-09-24
04015630912209Tinaquant Cardiac Creactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
04015630921508Cardiac CReactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
04015630928774Cardiac CReactive Protein Latex High SensitiveRoche Diagnostics GmbHNQD2016-09-20
10758750006885VITROSORTHO-CLINICAL DIAGNOSTICS, INC.NQD2016-08-26
15099590203160IMMAGEBeckman Coulter, Inc.NQD2016-08-24
15099590228682SynchronBeckman Coulter, Inc.NQD2016-08-24