Home GUDID 00816387020865
IMMY
Primary DI 00816387020865
Brand IMMY
Company Immuno-Mycologics, Inc.
Model SL1001
Device description LA-Sporothrix 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 GMA Antisera, Fluorescent, Sporothrix Schenekii
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GMA Antisera, Fluorescent, Sporothrix Schenekii Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816387020865 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 00816387020865 00816387020865 816387020865 0816387020865 00816387020612 00816387020612 816387020612 0816387020612
GMDN Terms# Term, Definition table Term Definition Sporothrix schenckii total antibody IVD, kit, agglutination 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 Sporothrix schenckii in a clinical specimen, using an agglutination method.
Regulatory Flags# DUNS number 099550915 Device count 80 Lot or batch true Expiration date on label true Other Devices From This Company#