510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QNHClass III

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

21 CFR 864.1860 / Hematology
FDA source (opens on fda.gov)

QNH is the FDA product code for Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay, a class III device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QNH
Device name
Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
FDA 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.
Regulation
21 CFR 864.1860
Device class
Class III
Review panel
Hematology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code