Home GUDID 00695684014018 SALMONELLA H b ANTIGEN
Primary DI 00695684014018
Brand SALMONELLA H b ANTIGEN
Company GERMAINE LABORATORIES, INC
Model 1401
Device description Salmonella H b Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.
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 GRL Antigens, All Groups, Salmonella Spp.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GRL Antigens, All Groups, Salmonella Spp. Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00695684014018 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 00695684014018 00695684014018 695684014018 0695684014018
GMDN Terms# Term, Definition table Term Definition Salmonella typhi antigen IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Salmonella typhi in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Salmonella typhi, the bacteria associated with typhoid fever.
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 05713106821510 S. Agona reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821527 S. Braenderup reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821534 S. Derby reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821541 S. Enteritidis reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821558 S. Hadar reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821572 S. Heidelberg reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821589 S. Infantis reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821602 S. Montevideo reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821619 S. Newport reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821626 S. Paratyphi A reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821633 S. Saintpaul reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821640 S. Senftenberg reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821657 S. Stanley reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821664 S. Typhimurium reference strain Ssi Diagnostica A/S GRL 2016-09-15 05713106821671 S. Virchow reference strain Ssi Diagnostica A/S GRL 2016-09-15 00382902117506 BD Difco™ QC Antigen Salmonella O Group E1 BECTON, DICKINSON AND COMPANY GRL 2016-07-07 00382902117513 BD Difco™ QC Antigen Salmonella O Group E2 BECTON, DICKINSON AND COMPANY GRL 2016-07-07 00382902117537 BD Difco™ QC Antigen Salmonella O Group F BECTON, DICKINSON AND COMPANY GRL 2016-07-07 00382902117544 BD Difco™ QC Antigen Salmonella O Group G1 BECTON, DICKINSON AND COMPANY GRL 2016-07-07 00382902117575 BD Difco™ QC Antigen Salmonella O Group I BECTON, DICKINSON AND COMPANY GRL 2016-07-07 00382902213017 BD Difco™ QC Antigen Salmonella O Group A BECTON, DICKINSON AND COMPANY GRL 2016-04-28 00382902213116 BD Difco™ QC Antigen Salmonella O Group B BECTON, DICKINSON AND COMPANY GRL 2016-04-28 00382902213215 BD Difco™ QC Antigen Salmonella O Group C1 BECTON, DICKINSON AND COMPANY GRL 2016-04-28 00382902213314 BD Difco™ QC Antigen Salmonella O Group C2 BECTON, DICKINSON AND COMPANY GRL 2016-04-28 00382902213413 BD Difco™ QC Antigen Salmonella O Group D BECTON, DICKINSON AND COMPANY GRL 2016-04-28 00382902213710 BD Difco™ QC Antigen Salmonella O Group E4 BECTON, DICKINSON AND COMPANY GRL 2016-04-28 00382902214014 BD Difco™ QC Antigen Salmonella O Group H BECTON, DICKINSON AND COMPANY GRL 2016-04-28 00382902214212 BD Difco™ QC Antigen Salmonella Vi BECTON, DICKINSON AND COMPANY GRL 2016-04-28 00695684015039 SALMONELLA O GROUP D ANTIGEN GERMAINE LABORATORIES, INC GRL 2016-04-27 00695684014001 SALMONELLA H a ANTIGEN GERMAINE LABORATORIES, INC GRL 2016-04-21