Home GUDID 00816387020322 IMMY
Primary DI 00816387020322
Brand IMMY
Company Immuno-Mycologics, Inc.
Model GLF065
Device description Lateral Flow Specimen Diluent
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 GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMD Antisera, Latex Agglutination, Cryptococcus Neoformans Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816387020322 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 00816387020322 00816387020322 816387020322 0816387020322
GMDN Terms# Term, Definition table Term Definition Cryptococcus neoformans 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 the yeast Cryptococcus neoformans in a clinical specimen.
Regulatory Flags# DUNS number 099550915 Device count 1 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 00848838026966 NA OXOID LIMITED GMD 2016-09-24 00848838028793 NA REMEL, INC. GMD 2016-09-24 00848838080913 NA REMEL, INC. GMD 2016-09-24 00816387020292 IMMY Immuno-Mycologics, Inc. GMD 2016-09-24 00816387020827 IMMY Immuno-Mycologics, Inc. GMD 2016-09-24 00816387020834 IMMY Immuno-Mycologics, Inc. GMD 2016-09-24 00816387020872 IMMY Immuno-Mycologics, Inc. GMD 2016-09-24 00816387020919 IMMY Immuno-Mycologics, Inc. GMD 2016-09-24 00840733101083 CALAS Pronase MERIDIAN BIOSCIENCE, INC. GMD 2016-09-23 00840733101090 Cryptococcal Antigen Latex Agglutination System (CALAS) MERIDIAN BIOSCIENCE, INC. GMD 2016-09-23
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