Home GUDID 00816387020834 IMMY
Primary DI 00816387020834
Brand IMMY
Company Immuno-Mycologics, Inc.
Model CR1004
Device description Latex-Cryptococcus Antigen Detection System
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 00816387020834 Primary GS1 0 00816387020889 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 00816387020834 00816387020834 816387020834 0816387020834 00816387020889 00816387020889 816387020889 0816387020889
GMDN Terms# Term, Definition table Term Definition Cryptococcus neoformans antigen IVD, kit, agglutination, rapid 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 within a short period, relative to standard laboratory testing procedures, using an agglutination method. This test is commonly used in the laboratory or in point-of-care analyses.
Regulatory Flags# DUNS number 099550915 Device count 120 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 00816387020322 IMMY Immuno-Mycologics, Inc. GMD 2016-09-24 00816387020827 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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