Home GUDID 00816387020759 IMMY
Primary DI 00816387020759
Brand IMMY
Company Immuno-Mycologics, Inc.
Model CRY101
Device description Cryptococcus Antigen 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 MDU Antigen, Elisa, Cryptococcus
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDU Antigen, Elisa, Cryptococcus Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816387020759 Primary GS1 0 00816387020766 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 00816387020759 00816387020759 816387020759 0816387020759 00816387020766 00816387020766 816387020766 0816387020766
GMDN Terms# Term, Definition table Term Definition Cryptococcus neoformans antigen IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the yeast Cryptococcus neoformans in a clinical specimen, using an enzyme immunoassay (EIA) method.
Regulatory Flags# DUNS number 099550915 Device count 96 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840733101229 PREMIER Cryptococcal Antigen MERIDIAN BIOSCIENCE, INC. MDU 2016-09-23
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