Identity
- Trade Name
- VIDAS TPSA ASSAY FDA PMA
- Generic Name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer FDA PMA
Identifiers
- PMA Number
- P040008 FDA PMA
- FDA Product Code
- MTF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Immunology FDA PMA
- FDA Decision
- APWD FDA PMA
The VIDAS Total PSA Assay is an automated enzyme-linked fluorescent immunoassay (ELFA) designed for quantitative measurement of total prostate-specific antigen (PSA) in human serum. Classified as a Total, prostate-specific antigen (noncomplexed & complexed) assay, it operates within the VIDAS (VITEK Immunodiagnostic Assay System) platform to support clinical decision-making in prostate cancer management.
Intended for use with the VIDAS instrument, this assay is supplied as a reagent kit for laboratory testing. It is not described as sterile or single-use in the provided data, though compliance with standard laboratory protocols for sample handling and assay preparation is implied. The device carries an FDA PMA authorization (P040008) and is categorized under product code MTF. Storage and handling details are not specified beyond typical laboratory conditions for immunoassay reagents.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040008 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
- FDA Applicant
- bioMerieux, Inc.
Sources (1)
- FDA PMA P040008 24 fields · synced Sep 18, 2026