PMA N50510S144
- Device
- VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S144
- Product code
- LTW
- Decision date
- 2001-06-13
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order 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, STAPHYLOCOCCUS EPIDERMIDIS, AND STREPTOCOCCUS AGALACTIAE ISOLATE TO QUINUPRISTIN/DALFOPRISTIN IN THE RANGE OF <=.5 TO >=4 MCG/ML.
Current openFDA PMA Record#
- Device
- VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S144
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2001-06-13
- Decision code
- APPR
- Date received
- 2001-01-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order 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, STAPHYLOCOCCUS EPIDERMIDIS, AND STREPTOCOCCUS AGALACTIAE ISOLATE TO QUINUPRISTIN/DALFOPRISTIN IN THE RANGE OF =4 MCG/ML.