PMA N50510S145
- Device
- VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S145
- Product code
- LTW
- Decision date
- 2001-06-25
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- APPROVAL FOR CHANGES IN THE ANTIBIOTIC DESIGN SPECIFICATION FOR THE ANTIBIOTIC TRIMETHOPRIM/SULFAMETHOXAZOLE AT CONCENTRATIONS OF 2/38, 8/152, 16/304, AND 32/608 UG/ML TO THE VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK 2 AND IS INDICATED FOR USE IN VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE ISOLATES TO TRIMETHOPRIM/SULFAMETHOXAZOLE IN THE RANGE OF <= .5/9.5 TO >= 16/304 UG/ML.
Current openFDA PMA Record#
- Device
- VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S145
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2001-06-25
- Decision code
- APPR
- Date received
- 2001-04-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES IN THE ANTIBIOTIC DESIGN SPECIFICATION FOR THE ANTIBIOTIC TRIMETHOPRIM/SULFAMETHOXAZOLE AT CONCENTRATIONS OF 2/38, 8/152, 16/304, AND 32/608 UG/ML TO THE VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK 2 AND IS INDICATED FOR USE IN VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE ISOLATES TO TRIMETHOPRIM/SULFAMETHOXAZOLE IN THE RANGE OF = 16/304 UG/ML.