Home GUDID B103A25CS30021 Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test
Primary DI B103A25CS30021
Brand Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test
Company International Point of Care Incorporated
Model CS3002
Catalog number CS3002
Device description Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
Published 2016-09-15
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name DEA Myoglobin, Fitc, Antigen, Antiserum, Control JHT Chromatographic Separation, Cpk Isoenzymes MMI Immunoassay Method, Troponin Subunit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DEA Myoglobin, Fitc, Antigen, Antiserum, Control Immunology 2 JHT Chromatographic Separation, Cpk Isoenzymes Clinical Chemistry 2 MMI Immunoassay Method, Troponin Subunit Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B103A25CS30021 Primary HIBCC 0 B103CS30020 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple cardiac marker IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative detection of one or a combination of cardiac markers in a clinical specimen, within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) 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. This test is commonly used in the laboratory or in point-of-care analyses.
Regulatory Flags# DUNS number 243942278 Device count 25 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 B103CSC30231 Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I) CSC3023 CSC3023 2022-12-07 B103A10CS10021 Cardiac STATus® TnI CS1002 CS1002 2016-09-15 B103A10CS30021 Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test CS3002 CS3002 2016-09-15 B103A20CS10021 Cardiac STATus® TnI CS1002 CS1002 2016-09-15 B103A20CS30021 Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test CS3002 CS3002 2016-09-15 B103A25CS10021 Cardiac STATus® TnI CS1002 CS1002 2016-09-15
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