PMA P940034S015
- Device
- GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S015
- Product code
- MWA
- Decision date
- 2004-02-10
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- CHANGE TO QC SPECIFICATION FOR THE RELEASE OF THE AMPLIFICATION REAGENT.
Current openFDA PMA Record#
- Device
- GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S015
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2004-02-10
- Decision code
- OK30
- Date received
- 2004-01-22
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO QC SPECIFICATION FOR THE RELEASE OF THE AMPLIFICATION REAGENT.