Home GUDID 00842768013829 Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge
Primary DI 00842768013829
Brand Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge
Company Siemens Healthcare Diagnostics Inc.
Model 10444904
Catalog number RF420
Device description Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name JHY COLORIMETRIC METHOD, CPK OR ISOENZYMES
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JHY Colorimetric Method, Cpk Or Isoenzymes Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842768013829 Primary GS1 0 00630414003924 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 00842768013829 00842768013829 842768013829 0842768013829 00630414003924 00630414003924 630414003924 0630414003924
GMDN Terms# Term, Definition table Term Definition Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using an enzyme immunoassay (EIA) method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 005088112 Device count 4 Lot or batch true Expiration date on label true 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
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