Atellica CH hsCRP

Primary DI
00630414596174
Brand
Atellica CH hsCRP
Company
Siemens Healthcare Diagnostics Inc.
Model
11097633
Catalog number
11097633
Device description
High Sensitivity C-Reactive Protein (hsCRP) Atellica CH - RGT 740T
Published
2017-12-21
Public version status
Update
Distribution status
Not 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
NQDCARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081294000ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORSSiemens Healthcare Diagnostics, Inc.2008-07-29NQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414596174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596174006304145961746304145961740630414596174

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
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
1
DM exempt
false
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
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
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
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414611112Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics Inc.NQD2024-06-11
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
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