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Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

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.

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Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
Hematology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QNH

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Class 3

21 CFR 864.1860

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Hematology

Device Characteristics

No

No

No

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.