Home GUDID 00695684017026
FRANCISELLA TULARENSIS ANTISERUM
Primary DI 00695684017026
Brand FRANCISELLA TULARENSIS ANTISERUM
Company GERMAINE LABORATORIES, INC
Model 1702
Device description Francisella Tularensis Antiserum is intended for use as a postive control for Francisella Tularensis Antigens.
Published 2016-04-21
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 GSK Antiserum, Francisella Tularensis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GSK Antiserum, Francisella Tularensis Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00695684017026 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 00695684017026 00695684017026 695684017026 0695684017026
GMDN Terms# Term, Definition table Term Definition Francisella tularensis total antibody IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Francisella tularensis in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Francisella tularensis, the bacteria associated with Tularaemia.
Regulatory Flags# DUNS number 176458115 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 00382902409397 BD Francisella Tularensis Antiserum BECTON, DICKINSON AND COMPANY GSK 2016-05-19