Home GUDID 00630414305028 Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Primary DI 00630414305028
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 New
Distribution status 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 00630414611112 Primary GS1 0 00630414305028 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00630414611112 00630414611112 630414611112 0630414611112 00630414305028 00630414305028 630414305028 0630414305028
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 Handling Environment Temperature 2 Degrees Celsius 8 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 064608573 Device count 2 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 00630414482446 ADVIA® Chemistry LIP Lipase Reagents 10311896 10311896 2020-09-24 00630414510149 ADVIA® Chemistry CHE Cholinesterase Reagents 10315176 10315176 2020-09-24 00630414526829 ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent 10335892 10335892 2020-09-24 00630414553191 ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated 10283347 10283347 2020-09-24 00842768013713 Dimension® CTNI Calibrator 10444986 10444986 2016-09-24 00842768016936 Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge 10444901 10444901 2016-09-24 00630414482385 ADVIA® Chemistry RF Rheumatoid Factor Reagents 10311894 10311894 2016-09-24 00630414513096 ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III) 10316612 10316612 2016-09-24 00630414513102 ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III) 10341116 10341116 2016-09-24 00630414517742 ADVIA® Chemistry C4 Complement C4 Reagents 10309054 10309054 2016-09-24 00630414590394 ADVIA® Chemistry TRIG_c Reagent 10697575 10697575 2016-09-24 00630414601199 ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator 10916060 10916060 2016-09-24 00630414947419 ADVIA® Chemistry Albumin BCP Reagents 10711841 10711841 2016-09-24 00630414947426 ADVIA® Chemistry Albumin BCP Calibrator 10711842 10711842 2016-09-24 00630414465401 ADVIA® Chemistry CHE Cholinesterase Reagents 10329639 10329639 2020-09-24 00630414534794 ADVIA® 1800 Analyzer 10315183 10315183 2020-09-24 00630414000510 VERSANT HCV Control 2.0 Kit (LiPA) 10719668 10719668 2017-09-15 00630414454597 ADVIA Centaur® FOL 10331250 10331250 2016-09-24 00630414482309 ADVIA® 1650 Chemistry System Ref. 10309442 10309442 2018-12-01 00630414569277 ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents 10379635 10379635 2016-09-24
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 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 00630414596174 Atellica CH hsCRP Siemens Healthcare Diagnostics Inc. NQD 2017-12-21 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
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