VIDAS TOTAL PSA
FDA premarket approval P040008/S005 · decided 2013-03-08
Approval details
- PMA number
- P040008
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIDAS TOTAL PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- bioMerieux, Inc.
- Date received
- 2013-02-06
- Decision date
- 2013-03-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- ADD AN ALTERNATE AUTOMATED PURIFICATION PROCESS TO SCALE-UP THE ANTI-PSA ANTIBODIES PRODUCTION USED IN THE MANUFACTURE OF THE VIDAS® TOTAL PSA (TPSA) ASSAY.
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