PMA N50510S143
- Device
- VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S143
- 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 GATIFLOXACIN AT CONCENTRATIONS OF 1, 4, AND 8 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 GATIFLOXACIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS AND STAPHYLOCOCCUS SAPROPHYTICUS ISOLATES TO GATIFLOXACIN IN THE RANGE OF <=0.5 TO >=8 MCG/ML.
Current openFDA PMA Record#
- Device
- VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S143
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2001-06-13
- Decision code
- APPR
- Date received
- 2000-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC GATIFLOXACIN AT CONCENTRATIONS OF 1, 4, AND 8 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 GATIFLOXACIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS AND STAPHYLOCOCCUS SAPROPHYTICUS ISOLATES TO GATIFLOXACIN IN THE RANGE OF =8 MCG/ML.