Home GUDID 00630414596198 Atellica CH CRP_2
Primary DI 00630414596198
Brand Atellica CH CRP_2
Company Siemens Healthcare Diagnostics Inc.
Model 11097631
Catalog number 11097631
Device description C-Reactive Protein_2 (CRP_2) Atellica CH - RGT 1000T
Published 2017-12-27
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 DCK C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL DCN SYSTEM, TEST, C-REACTIVE PROTEIN
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology 2 DCN System, Test, C-Reactive Protein Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00630414596198 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 00630414596198 00630414596198 630414596198 0630414596198
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 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 00816426021549 K-ASSAY® CRP Reagent (Ver.2) KAMIYA BIOMEDICAL COMPANY, LLC DCK 2026-02-27 00816426021556 K-ASSAY® CRP Calibrator (Ver.2) KAMIYA BIOMEDICAL COMPANY, LLC DCK 2026-02-27 08100322954295 ProciseDx Calibration Cartridge Chembio Diagnostic Systems Inc. DCK 2024-08-06 08100322943909 ProciseDx Analyzer Chembio Diagnostic Systems Inc. DCK 2024-08-05 10673486002430 Teco Diagnostics C-Reactive Protein (CRP) Reagent Set TECO DIAGNOSTICS DCK 2024-04-02 00630414610887 Atellica CH Revised C-Reactive Protein (RCRP) Siemens Healthcare Diagnostics Inc. DCN 2024-02-02 00630414305127 Atellica CH Revised C-Reactive Protein (RCRP) Siemens Healthcare Diagnostics Inc. DCN 2024-02-02 04048474039542 C-Reactive Protein HS ELISA DRG Instruments Gesellschaft mit beschränkter Haftung DCK 2023-08-31 00895160002694 Nano-Check TM CRP plus Test NANO-DITECH CORPORATION DCN 2022-03-15 10895160002691 Nano-Check TM CRP plus Test NANO-DITECH CORPORATION DCN 2022-03-15 00894175000312 AccuDiag™ Diagnostic Automation, Inc. DCN 2021-08-26 00811727015815 Pointe CRP Reagent HORIBA INSTRUMENTS INCORPORATED DCK 2021-01-30 00811727016126 Pointe CRP Reagent HORIBA INSTRUMENTS INCORPORATED DCK 2021-01-30 00895160002670 Fluoro-CheckTM CRP Test NANO-DITECH CORPORATION DCN 2020-09-22 10895160002677 Fluoro-CheckTM CRP Test NANO-DITECH CORPORATION DCN 2020-09-22 03610230007297 Yumizen C1200 CRP HORIBA ABX SAS DCK 2020-07-13 00083059070330 HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT BIOMERICA, INC. DCK 2020-07-01 07613336121191 Tina-quant C-Reactive Protein IV Roche Diagnostics GmbH DCN 2020-06-16 10758750001637 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. DCK 2020-05-16 10758750001965 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. DCK 2020-05-16 10758750006915 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. DCK 2020-05-16 04015630946839 Tina-quant CReactive Protein IV Roche Diagnostics GmbH DCN 2020-05-13 04015630946846 Tina-quant CReactive Protein IV Roche Diagnostics GmbH DCN 2020-05-13 04015630946853 Tina-quant CReactive Protein IV Roche Diagnostics GmbH DCN 2020-05-13 10758750005062 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. DCK 2020-04-18 10758750005208 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. DCK 2020-04-18 07613336121184 C-Reactive Protein Gen.3 Roche Diagnostics GmbH DCN 2020-03-05 00380740180331 Alinity ABBOTT LABORATORIES DCK 2020-01-13 00850392007190 BioCheck High Sensitive CRP EIA Test Kit BIOCHECK, INC. DCK 2019-10-08 00840239039545 C-Reactive Protein HS ELISA DRG International Inc DCK 2019-03-20
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