VIDAS TOTAL PSA
FDA premarket approval P040008/S011 · decided 2015-04-22
Approval details
- PMA number
- P040008
- Supplement
- S011
- 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
- 2015-03-18
- Decision date
- 2015-04-22
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- CHANGE TO REMOVE EXTRANEOUS IN-PROCESS STABILITY TESTS PERFORMED ON THE STRIPS (STR) AND ON THE SOLID PHASE RECEPTACLES (SPR) OF THE KIT, AND CONSEQUENTLY TO ADD AN INSTRUCTION FOR THE STORAGE OF THE STR DURING THE MANUFACTURING PROCESS.
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