PMA P040008S007
- Device
- VIDAS TOTAL PSA (TPSA) ASSAY
- Applicant
- bioMerieux, Inc.
- PMA number
- P040008
- Supplement
- S007
- Product code
- MTF
- Decision date
- 2013-09-12
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- REVIEW OF BIOMÉRIEUX¿S EXPANSION TO THE MANUFACTURING FACILITY IN MARCY L¿ETOILE (FRANCE).
Current openFDA PMA Record#
- Device
- VIDAS TOTAL PSA (TPSA) ASSAY
- Applicant
- bioMerieux, Inc.
- PMA number
- P040008
- Supplement
- S007
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2013-09-12
- Decision code
- OK30
- Date received
- 2013-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REVIEW OF BIOMÉRIEUX¿S EXPANSION TO THE MANUFACTURING FACILITY IN MARCY L¿ETOILE (FRANCE).