PMA N50510S142
- Device
- VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S142
- Product code
- LTW
- Decision date
- 2001-05-30
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- APPROVAL FOR THE ADDITION TO THE VITEK. GRAM POSITIVE SUSCEPTIBILITY PANELS, THE ANTIBIOTIC MOXIFLOXACIN AT EQUIVALENT CONCENTRATIONS OF 1, 2, AND 4 MCG/ML. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR MOXIFLOXACIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO MOXIFLOXACIN IN THE RANGE OF <=0.25 TO >=8 MCG/ML.
Current openFDA PMA Record#
- Device
- VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S142
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2001-05-30
- Decision code
- APPR
- Date received
- 2000-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR THE ADDITION TO THE VITEK. GRAM POSITIVE SUSCEPTIBILITY PANELS, THE ANTIBIOTIC MOXIFLOXACIN AT EQUIVALENT CONCENTRATIONS OF 1, 2, AND 4 MCG/ML. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR MOXIFLOXACIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO MOXIFLOXACIN IN THE RANGE OF =8 MCG/ML.