FDA product code QNH

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Hematology·Class 3·21 CFR 864.1860
US regulatory classifications
US Product Code (FDA)
QNH
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 864.1860
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Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.