VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN

FDA premarket approval N50510/S144 · decided 2001-06-13

Approval details

PMA number: N50510
Supplement: S144
Supplement type: Normal 180 Day Track
Supplement reason: Other
Trade name: VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN
Generic name: Susceptibility test cards, antimicrobial
Applicant: Biomerieux Vitek, Inc.
Date received: 2001-01-03
Decision date: 2001-06-13
Days to decision: 161 days
Decision code: APPR
Product code: LTW
Advisory committee: Microbiology
Expedited review: No
Location: Hazelwood, MO
Statement: APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC QUINUPRISTIN/DALFOPRISTIN AT CONCENTRATIONS OF 0.75, 1.5, AND 3 MCG/ML TO THE VITEK. GRAM POSITIVE SUSCEPTIBILITY PANEL. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS, VANCOMYCIN-RESISTANT ENTEROCOCCUS FAECIUM, STAPHYLOC

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Record	Firm	Date
VIDAS D-DIMER (DD) ASSAY (K973819)	Biomerieux Vitek, Inc.	1998-03-10
VIDAS ROTAVIRUS (RTV) ASSAY (K972895)	Biomerieux Vitek, Inc.	1997-10-03
VIDAS ROTAVIRUS ASSAY (K965092)	Biomerieux Vitek, Inc.	1997-05-05
VIDAS C. DIFFICILE TOXIN A II ASSAY (K964887)	Biomerieux Vitek, Inc.	1997-04-08
VIDAS CHLAMYDIA BLOCKING ASSAY (K955627)	Biomerieux Vitek, Inc.	1996-10-07
VIDAS CREATINE KINASE MB ASSAY 30-421 (K962549)	Biomerieux Vitek, Inc.	1996-08-30
GRAM NEGATIVE IDENTIFICATION PLUS CARD (K962609)	Biomerieux Vitek, Inc.	1996-08-30
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (K952095)	Biomerieux Vitek, Inc.	1996-03-12