PMA P940034
- Device
- AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S019
- Product code
- MWA
- Decision date
- 2012-12-05
- Classification
- System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- CHANGE IN THE AMPLIFICATION POSITIVE CONTROL USED FOR QUALITY CONTROL TESTING.
Current openFDA PMA Record#
- Device
- AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S019
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2012-12-05
- Decision code
- OK30
- Date received
- 2012-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE AMPLIFICATION POSITIVE CONTROL USED FOR QUALITY CONTROL TESTING.