Identity
- Trade Name
- VENTANA MMR RxDx Panel FDA PMA
- Generic Name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay FDA PMA
Identifiers
- PMA Number
- P200019 FDA PMA
- FDA Product Code
- QNH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 864.1860 FDA PMA
- Regulation Number
- 864.1860 FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Ventana Anti-MSH6 (SP93) Antibody is an Immunohistochemistry Test, DNA Mismatch Repair (MMR) Protein Assay, used to detect MSH6 protein expression in tissue samples. It is classified as a Class III device under FDA regulations and falls within the Pathology advisory committee category (PA). This assay aids in identifying mismatch repair deficiency (dMMR) status in endometrial cancer patients, supporting treatment decision-making for therapies like Jemperli.
This antibody is supplied as part of the Ventana MMR RxDx Panel and is intended for use in clinical laboratories with immunohistochemistry (IHC) capabilities. It is not specified as single-use or reusable in the provided data, though IHC reagents are typically used in a controlled laboratory setting with appropriate sterility measures. The product is authorized under FDA PMA (P200019) and is regulated under 21 CFR 864.1860. Storage and handling conditions align with standard IHC reagent protocols, as detailed in the manufacturer’s instructions.
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. Sources consulted: VENTANA® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, Home | Ventana
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P200019 | Class III | Active |
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Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA PMA P200019 24 fields · synced Oct 6, 2026