VIDAS FREE PSA (FPSA) ASSAY
FDA premarket approval P080008/S001 · decided 2012-02-08
Approval details
- PMA number
- P080008
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIDAS FREE PSA (FPSA) ASSAY
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- bioMerieux, Inc.
- Date received
- 2012-01-09
- Decision date
- 2012-02-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- ADD AN ALTERNATE SUPPLIER OF THE CRITICAL COMPONENT SOLID PHASE RECEPTACLE (SPR-PM) FOR THE VIDAS® TOTAL PSA AND FREE PSA PRODUCTS.
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