PMA P040008
- Device
- VIDAS TOTAL PSA
- Applicant
- bioMerieux, Inc.
- PMA number
- P040008
- Supplement
- S013
- Product code
- MTF
- Decision date
- 2016-05-31
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Change of subcontractor of mouse ascite.
Current openFDA PMA Record#
- Device
- VIDAS TOTAL PSA
- Applicant
- bioMerieux, Inc.
- PMA number
- P040008
- Supplement
- S013
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2016-05-31
- Decision code
- OK30
- Date received
- 2016-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of subcontractor of mouse ascite.