- Device
- VIDAS TOTAL PSA (TPSA) ASSAY
- Applicant
- bioMerieux, Inc.
- PMA number
- P040008
- Supplement
- S008
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2014-03-06
- Decision code
- OK30
- Date received
- 2014-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR THE CRITICAL COMPONENT: 4 AND 8 ML CAPACITY GLASS VIALS.