Home GUDID 10634853000015
Fungal Serology
Primary DI 10634853000015
Brand Fungal Serology
Company MICROBIOLOGICS INC.
Model 200125
Catalog number 200125
Device description Blastomyces dermatitidis Antigen (A), 1mL
Published 2016-09-15
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true
Product Codes# Code, Name table Code Name JWW Antigen, Cf, B. Dermatitidis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWW Antigen, Cf, B. Dermatitidis Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10634853000015 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10634853000015 10634853000015
GMDN Terms# Term, Definition table Term Definition Blastomyces dermatitidis 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 Blastomyces dermatitidis in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Can be kept at -20 deg C. However, do not freeze and thaw repeatedly. Storage Environment Temperature -20 Degrees Celsius -20 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 060467826 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 10634853000022 Fungal Serology MICROBIOLOGICS INC. JWW 2016-09-15