Home GUDID 00842768004544 Stratus® CS Acute Care™ cTNI DilPak
Primary DI 00842768004544
Brand Stratus® CS Acute Care™ cTNI DilPak
Company Siemens Healthcare Diagnostics Inc.
Model 10445073
Catalog number CCTNI-D
Device description The Stratus® CS Acute Care™ Cardiac Troponin I Dilution Pak (cTNI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTNI TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of cardiac Troponin I.
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name DDR MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES JIT CALIBRATOR, SECONDARY MMI IMMUNOASSAY METHOD, TROPONIN SUBUNIT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DDR Myoglobin, Antigen, Antiserum, Control Immunology 2 JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry 2 JIT Calibrator, Secondary Clinical Chemistry 2 MMI Immunoassay Method, Troponin Subunit Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842768004544 Primary GS1 0 00630414009872 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 00842768004544 00842768004544 842768004544 0842768004544 00630414009872 00630414009872 630414009872 0630414009872
GMDN Terms# Term, Definition table Term Definition Troponin I IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using a fluorescent immunoassay method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
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