VIDAS TOTAL PSA (TPSA) ASSAY
FDA premarket approval P040008/S008 · decided 2014-03-06
Approval details
- PMA number
- P040008
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIDAS TOTAL PSA (TPSA) ASSAY
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- bioMerieux, Inc.
- Date received
- 2014-02-03
- Decision date
- 2014-03-06
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR THE CRITICAL COMPONENT: 4 AND 8 ML CAPACITY GLASS VIALS.
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