PMA P940040S001
- Device
- ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P940040
- Supplement
- S001
- Product code
- MWA
- Decision date
- 2000-09-12
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- APPROVAL FOR CURRENT FACILITY PLANS, REVISED BATCH RECORDS, REVISED QC SPECIFICATIONS, REVISED PACKAGING ORDERS AND REVISED LABELS.
Current openFDA PMA Record
- Device
- ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P940040
- Supplement
- S001
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2000-09-12
- Decision code
- APPR
- Date received
- 2000-07-26
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR CURRENT FACILITY PLANS, REVISED BATCH RECORDS, REVISED QC SPECIFICATIONS, REVISED PACKAGING ORDERS AND REVISED LABELS.