Home GUDID 00816387020704 IMMY
Primary DI 00816387020704
Brand IMMY
Company Immuno-Mycologics, Inc.
Model BTA101
Device description OMEGA Blastomyces Total Antibody EIA
Published 2016-09-24
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 MJL Eia, Blastomyces Dermatitidis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MJL Eia, Blastomyces Dermatitidis Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816387020704 Primary GS1 0 00816387020711 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 00816387020704 00816387020704 816387020704 0816387020704 00816387020711 00816387020711 816387020711 0816387020711
GMDN Terms# Term, Definition table Term Definition Blastomyces dermatitidis total antibody 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 total antibodies to the fungus Blastomyces dermatitidis in a clinical specimen.
Regulatory Flags# DUNS number 099550915 Device count 96 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# 
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