Home GUDID 00816387020216 IMMY
Primary DI 00816387020216
Brand IMMY
Company Immuno-Mycologics, Inc.
Model C40110
Device description Coccidioides IDCF Positive Control
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 GMH Antiserum, Positive Control, Coccidioides Immitis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMH Antiserum, Positive Control, Coccidioides Immitis Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816387020216 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 00816387020216 00816387020216 816387020216 0816387020216
GMDN Terms# Term, Definition table Term Definition Coccidioides immitis total antibody IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the fungus Coccidioides immitis in a clinical specimen.
Regulatory Flags# DUNS number 099550915 Device count 1 Premarket exempt true 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 00816387020193 IMMY Immuno-Mycologics, Inc. GMH 2016-09-24 00816387020278 IMMY Immuno-Mycologics, Inc. GMH 2016-09-24 00840733101069 "Anti-Coccidioides ""F"" Control Serum for Fungal Immunodiffusion" MERIDIAN BIOSCIENCE, INC. GMH 2016-09-23 00840733101359 "Anti-Coccidioides ""TP"" Control Serum for Immunodiffusion" MERIDIAN BIOSCIENCE, INC. GMH 2016-09-23 10634853000077 Fungal Serology MICROBIOLOGICS INC. GMH 2016-09-15 10634853000084 Fungal Serology MICROBIOLOGICS INC. GMH 2016-09-15
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