FDA.reportPublic FDA data

Multiple antimycobacterial susceptibility testing kit IVD

Definition
A collection of reagents and other associated materials containing multiple susceptibility testing discs impregnated with a range of antimycobacterial agents (i.e., drugs intended for treatment and/or prevention of a mycobacterial infection) intended to be used to determine the antimicrobial susceptibility profile of a specific Mycobacterium organism, isolated from a clinical specimen by culture.
GUDID devices
10
Last updated
2022-12-12 07:38:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05032384007189AN-IDENT DISCSDD6 6X50 DISCSOXOID LIMITEDDD0006A2022-12-04
00382902315704BD BBL™ Sensi-Disc™ Streptomycin - 50 µgBECTON, DICKINSON AND COMPANY2315702016-05-03
00382902315711BD BBL™ Sensi-Disc™ Isoniazid - 1 µgBECTON, DICKINSON AND COMPANY2315712016-05-03
00382902315728BD BBL™ Sensi-Disc™ Isoniazid - 5 µgBECTON, DICKINSON AND COMPANY2315722016-05-03
00382902315735BD BBL™ Sensi-Disc™ P-Aminosalicylic Acid - 10 µgBECTON, DICKINSON AND COMPANY2315732016-05-03
00382902315742BD BBL™ Sensi-Disc™ P-Aminosalicylic Acid - 50 µgBECTON, DICKINSON AND COMPANY2315742016-05-03
00382902315759BD BBL™ Sensi-Disc™ Ethambutol - 25 µgBECTON, DICKINSON AND COMPANY2315752016-05-03
00382902315766BD BBL™ Sensi-Disc™ Ethambutol - 50 µgBECTON, DICKINSON AND COMPANY2315762016-05-03
00382902315773BD BBL™ Sensi-Disc™ Ethionamide - 25 µgBECTON, DICKINSON AND COMPANY2315772016-05-03
00382902315780BD BBL™ Sensi-Disc™ Rifampin - 25 µgBECTON, DICKINSON AND COMPANY2315782016-05-03