Home GUDID 00816387020810 IMMY
Primary DI 00816387020810
Brand IMMY
Company Immuno-Mycologics, Inc.
Model CL1001
Device description Latex Agglutination - Coccidioides Antibody 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 GMG Antigen, Latex Agglutination, Coccidioides Immitis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMG Antigen, Latex Agglutination, Coccidioides Immitis Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816387020810 Primary GS1 0 00816387020612 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 00816387020810 00816387020810 816387020810 0816387020810 00816387020612 00816387020612 816387020612 0816387020612
GMDN Terms# Term, Definition table Term Definition Coccidioides immitis total antibody IVD, kit, agglutination, rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the fungus Coccidioides immitis 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 80 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# 
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