PMA N50510S141
- Device
- VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S141
- Product code
- LTW
- Decision date
- 2001-05-14
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC SPARFLOXACIN AT CONCENTRATIONS OF 0.5, 1.0, AND 8.0 MCG/ML TO THE VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK. 2 GRAM POSITIVE AST FOR SPARFLOXACIN AND IS INDICATED FOR USE IN VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO SPARFLOXACIN IN THE RANGE OF <= 0.25 TO >= 8 MCG/ML.
Current openFDA PMA Record#
- Device
- VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S141
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2001-05-14
- Decision code
- APPR
- Date received
- 2000-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC SPARFLOXACIN AT CONCENTRATIONS OF 0.5, 1.0, AND 8.0 MCG/ML TO THE VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK. 2 GRAM POSITIVE AST FOR SPARFLOXACIN AND IS INDICATED FOR USE IN VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO SPARFLOXACIN IN THE RANGE OF = 8 MCG/ML.