Home GUDID 00812125010082 mecA XpressFISH®
Primary DI 00812125010082
Brand mecA XpressFISH®
Company ADVANDX, INC.
Model KT601
Catalog number KT601
Device description 25 tests per kit
Published 2016-11-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MYI SYSTEM,TEST,GENOTYPIC DETECTION,RESISTANT MARKERS,STAPHYLOCOCCUS COLONIES
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812125010082 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 00812125010082 00812125010082 812125010082 0812125010082
GMDN Terms# Term, Definition table Term Definition Staphylococcus aureus culture isolate antigen IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Staphylococcus aureus bacteria isolated by culture from a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 145416900 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices Sharing Product Codes# 
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