VIDAS TPSA ASSAY
FDA premarket approval P040008 · decided 2004-07-08
Approval details
- PMA number
- P040008
- Trade name
- VIDAS TPSA ASSAY
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- bioMerieux, Inc.
- Date received
- 2004-02-17
- Decision date
- 2004-07-08
- Days to decision
- 142 days
- Decision code
- APWD
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR THE VIDAS TPSA ASSAY INDICATED AS FOLLOWS: VIDAS TPSA IS INTENDED FOR USE WITH A VIDAS (VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM) INSTRUMENT AS AN AUTOMATED ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM. THE VIDAS TPSA ASSAY IS INDICATED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATE CANCER AND AS AN AID IN THE DETECTION OF PROSTATE CANCER IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN A
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