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U.S. Department of Health and Human Services

Product Classification

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Device braf mutation kit
Definition The BRAF mutation kit is a multiplex qualitative in vitro diagnostic device to identify specific BRAF mutations by multiplex polymerase chain reaction of genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue. It is intended to aid in the treatment decisions and risk stratification of patients diagnosed with colorectal or papillary thyroid cancer.
Physical State Multiplex qualitative DNA mutation amplification and detection test system. Should not include products not intended for export only or for products intended for re-importation into the USA.
Technical Method The test uses multiplex qualitative polymerase chain reaction (PCR) and a multiplex test system (e.g., liquid bead array cytometry, etc.) to amplify and detect specific BRAF mutations.
Target Area Formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue.
Review Panel Immunology
Product CodePAN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible