PMA P940034S017
- Device
- GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S017
- Product code
- MWA
- Decision date
- 2007-07-18
- Classification
- System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- APPROVAL FOR A CHANGE TO A QUALITY CONTROL RELEASE SPECIFICATION FOR THE ENZYME REAGENT, A COMPONENT OF THE MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST.
Current openFDA PMA Record#
- Device
- GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S017
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2007-07-18
- Decision code
- APPR
- Date received
- 2006-07-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- APPROVAL FOR A CHANGE TO A QUALITY CONTROL RELEASE SPECIFICATION FOR THE ENZYME REAGENT, A COMPONENT OF THE MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST.