PMA P940040S006
- Device
- AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P940040
- Supplement
- S006
- Product code
- MWA
- Decision date
- 2005-12-14
- Classification
- Microbiology
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- CHANGE TO THE PURIFICATION PROCESS.
Current openFDA PMA Record#
- Device
- AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P940040
- Supplement
- S006
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2005-12-14
- Decision code
- OK30
- Date received
- 2005-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE PURIFICATION PROCESS.