PMA N50510S133
- Device
- VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S133
- Product code
- LTW
- Decision date
- 2000-06-09
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC BENZYLPENICILLIN AT CONCENTRATIONS OF 0.03, 0.06, 0.25 AND 0.5 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO BENZYLPENICILLIN IN THE RANGE OF <=0.06 TO >=2 MICROGRAMS/ML.
Current openFDA PMA Record#
- Device
- VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S133
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2000-06-09
- Decision code
- APPR
- Date received
- 2000-04-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC BENZYLPENICILLIN AT CONCENTRATIONS OF 0.03, 0.06, 0.25 AND 0.5 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO BENZYLPENICILLIN IN THE RANGE OF =2 MICROGRAMS/ML.