PMA P040008S001
- Device
- VIDAS TOTAL PSA (TPSA) ASSAY
- Applicant
- bioMerieux, Inc.
- PMA number
- P040008
- Supplement
- S001
- Product code
- MTF
- Decision date
- 2008-09-25
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- CHANGE OF VENDOR FOR THE MOUSE MONOCLONAL ANTIBODY USED IN THE MANUFACTURE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- VIDAS TOTAL PSA (TPSA) ASSAY
- Applicant
- bioMerieux, Inc.
- PMA number
- P040008
- Supplement
- S001
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2008-09-25
- Decision code
- OK30
- Date received
- 2008-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF VENDOR FOR THE MOUSE MONOCLONAL ANTIBODY USED IN THE MANUFACTURE OF THE DEVICE.