PMA N50510S140
- Device
- VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S140
- Product code
- LTW
- Decision date
- 2001-03-09
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC MINOCYCLINE AT CONCENTRATIONS OF 0.125, 0.5, AND 1 UG/ML TO THE VITEK(R) 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 AND INDICATED FOR USE IN VITEK(R) 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF GRAM POSITIVE ISOLATES TO MINOCYCLINE IN THE RANGE OF <=0.5 TO >=16 UG/ML.
Current openFDA PMA Record#
- Device
- VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S140
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2001-03-09
- 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 MINOCYCLINE AT CONCENTRATIONS OF 0.125, 0.5, AND 1 UG/ML TO THE VITEK(R) 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 AND INDICATED FOR USE IN VITEK(R) 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF GRAM POSITIVE ISOLATES TO MINOCYCLINE IN THE RANGE OF =16 UG/ML.