Home GUDID 00630414596174 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
Product Codes# Code, Name table Code Name NQD CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00630414596174 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00630414596174 00630414596174 630414596174 0630414596174
GMDN Terms# Term, Definition table Term Definition C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry A 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 Type Low High Condition Storage Environment Temperature 0 0
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 DI Brand Model Catalog Published 00630414596167 Atellica CH ASO_2 11097634 11097634 2020-09-24 00630414596259 Atellica CH PreAlb 11097617 11097617 2020-09-24 00630414596440 Atellica CH GGT 11097597 11097597 2020-09-24 00630414596198 Atellica CH CRP_2 11097631 11097631 2017-12-27 00630414597508 Atellica CH hsCRP Calibrator 11099412 11099412 2017-12-22 00630414597515 Atellica CH CRP_2 Calibrator 11099430 11099430 2017-12-22 00630414611075 Atellica CH Crea3 11537215 11537215 2026-05-08 00630414611297 Atellica CH RCRP Cal 11537245 11537245 2024-02-02 00842768037726 Dimension EXL LOCI Troponin I High Sensitive 10471068 10471068 2019-10-16 00630414596099 Atellica CH Thc 11097503 11097503 2017-12-27 00630414510156 ADVIA® Chemistry PAMY Pancreatic Amylase Reagents 10315178 1410820 2016-09-24 00630414595641 Atellica CH PAmy 11097622 11097622 2017-12-21 00630414608273 ADVIA Centaur Tumor Marker Quality Control (TM QC) 11538186 11538186 2026-05-29 00630414622859 Atellica IM Tumor Marker Quality Control (TM QC) 11538187 11538187 2026-05-29 00630414517681 ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents 10318208 3055483 2020-09-24 00842768016912 Dimension® PBNP Calibrator 10445008 RC423A 2016-09-24 00630414498942 ADVIA® Chemistry ACET Acetaminophen Reagents 10327381 7989138 2016-09-24 00630414568768 ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents 10378760 10378760 2016-09-24 00630414653259 Atellica CH Crea3 11537567 11537567 2026-05-08 00630414618456 ADVIA CENTAUR ELF MCM SET 11208709 11208709 2023-03-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00630414611112 Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) Siemens Healthcare Diagnostics Inc. NQD 2024-06-11 00630414305028 Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) Siemens Healthcare Diagnostics Inc. NQD 2024-06-11 07613336121207 Cardiac C-Reactive Protein (Latex) High Sensitive Roche Diagnostics GmbH NQD 2020-03-05 00380740180331 Alinity ABBOTT LABORATORIES NQD 2020-01-13 00380740181024 Alinity ABBOTT LABORATORIES NQD 2020-01-13 00380740158491 ARCHITECT ABBOTT LABORATORIES NQD 2018-12-28 00380740158507 ARCHITECT ABBOTT LABORATORIES NQD 2018-12-28 15099590010959 AU Beckman Coulter, Inc. NQD 2016-09-24 00842768006135 Dimension Vista hsCRP Flex reagent cartridge Siemens Healthcare Diagnostics Products GmbH NQD 2016-09-24 00842768007729 CardioPhase® hsCRP Siemens Healthcare Diagnostics Products GmbH NQD 2016-09-24 00842768007736 CardioPhase® hsCRP Siemens Healthcare Diagnostics Products GmbH NQD 2016-09-24 00842768016028 Dimension CardioPhase high sensitivity CRP Flex reagent cartridge Siemens Healthcare Diagnostics Inc. NQD 2016-09-24 00630414552699 ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Siemens Healthcare Diagnostics Inc. NQD 2016-09-24 00630414953144 IMMULITE® Systems CRP CONTROL C-Reactive Protein SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD NQD 2016-09-24 00630414953670 IMMULITE®/IMMULITE® 1000 Systems CRP Sample Diluent SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD NQD 2016-09-24 00630414953687 IMMULITE® 2000 Systems CRP CRP Sample Diluent SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD NQD 2016-09-24 00630414961200 IMMULITE® 2000 Systems hsC High Sensitivity CRP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD NQD 2016-09-24 00630414963792 IMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD NQD 2016-09-24 04015630912209 Tinaquant Cardiac Creactive Protein Latex High Sensitive Roche Diagnostics GmbH NQD 2016-09-20 04015630921508 Cardiac CReactive Protein Latex High Sensitive Roche Diagnostics GmbH NQD 2016-09-20 04015630928774 Cardiac CReactive Protein Latex High Sensitive Roche Diagnostics GmbH NQD 2016-09-20 10758750006885 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. NQD 2016-08-26 15099590203160 IMMAGE Beckman Coulter, Inc. NQD 2016-08-24 15099590228682 Synchron Beckman Coulter, Inc. NQD 2016-08-24