- Device
- AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST
- Applicant
- Gen-Probe, Inc.
- PMA number
- P940034
- Supplement
- S018
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2010-04-23
- Decision code
- OK30
- Date received
- 2010-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF LOCATION FOR A QC LAB TO SEGREGATE THE PRE- AND POST-AMPLIFICATION STEPS INTO SEPARATE ROOMS.