Identity
- Trade Name
- VIDAS FREE PSA RT ASSAY FDA PMA
- Generic Name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions FDA PMA
Identifiers
- PMA Number
- P080008 FDA PMA
- FDA Product Code
- MTG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Immunology FDA PMA
- FDA Decision
- APWD FDA PMA
The VIDAS Free PSA RT Assay is an automated quantitative test for measuring the free fraction of prostate-specific antigen (PSA) in human serum using the enzyme-linked fluorescent assay (ELFA) technique. Classified as a Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer From Benign Conditions, it is designed for use on VIDAS instruments to aid in differentiating prostate cancer from benign prostate conditions in men aged 50 or older with total PSA values between 4 and 10 ng/mL.
This assay is intended for use alongside the VIDAS Total PSA (TPSA) assay and requires prostate biopsy for definitive prostate cancer diagnosis. Supplied as a single-use reagent, it operates on automated VIDAS platforms and is regulated under FDA_PMA approval (PMA P080008). No sterility or MRI safety considerations apply, as it is a laboratory-based diagnostic test.
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 | P080008 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomerieux , Inc.
- FDA Applicant
- bioMerieux, Inc.
Sources (1)
- FDA PMA P080008 24 fields · synced Oct 6, 2026