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FDA PMA

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay

PMA Number: P210001 · 2026-10-08

ApplicantVentana Medical Systems, Inc. (Roche Tissue Diagnostics)
Decision Date2026-10-08
PMA NumberP210001
Product CodeQNH
Device ClassClass 3
Medical SpecialtyH
Regulation Number21 CFR 8
Advisory CommitteePA

Device Summary

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2026-10-08. The device is classified under product code QNH. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay?

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay is a medical device that received FDA 510(k) clearance on 2026-10-08. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).

When did Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay?

The FDA 510(k) record lists Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay?

The FDA product code for Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay is QNH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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