Home GUDID 00842768004629 Stratus® CS Acute Care™ MYO DilPak
Primary DI 00842768004629
Brand Stratus® CS Acute Care™ MYO DilPak
Company Siemens Healthcare Diagnostics Inc.
Model 10445081
Catalog number CMYO-D
Device description The Stratus® CS Acute Care(TM) Myoglobin Dilution Pak (MYO DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) MYO TestPak for the measurement of samples with elevated levels of Myoglobin.
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 00842768004629 Primary GS1 0 00630414009940 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 00842768004629 00842768004629 842768004629 0842768004629 00630414009940 00630414009940 630414009940 0630414009940
GMDN Terms# Term, Definition table Term Definition Myoglobin IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the quantitative measurement of myoglobin 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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