FDA product code QNH: Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
QNH is the FDA product code for immunohistochemistry test, dna mismatch repair (mmr) protein assay. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under QNH reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
Definition
The DNA Mismatch Repair Protein Antibody is a qualitative immunohistochemical antibody intended for the assessment of mismatch repair (MMR) proteins in human clinical tissue specimens. The DNA Mismatch Repair Protein Antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for QNH devices
openFDA lists no recalls for product code QNH.
Frequently asked questions
What is FDA product code QNH?
QNH is the FDA product code for immunohistochemistry test, dna mismatch repair (mmr) protein assay. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is QNH?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QNH
- Run a recall and safety report across every QNH manufacturer
- Watch product code QNH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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