PMA P940040S004
- Device
- AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P940040
- Supplement
- S004
- Product code
- MWA
- Decision date
- 2004-06-23
- Classification
- Microbiology
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Approval order statement
- CHANGE IN PROCESS POINTS AT WHICH CHEMICAL AND FUNCTIONAL TESTING ARE PERFORMED.
Current openFDA PMA Record#
- Device
- AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P940040
- Supplement
- S004
- Product code
- MWA
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Decision date
- 2004-06-23
- Decision code
- OK30
- Date received
- 2004-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN PROCESS POINTS AT WHICH CHEMICAL AND FUNCTIONAL TESTING ARE PERFORMED.