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U.S. Department of Health and Human Services

Product Classification

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Device somatic gene mutation detection system
Definition The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in dna extracted from human tumor tissues.
Physical State Test consists of reagents, instrumentation, software and instructions needed to perform the test method.
Technical Method In vitro amplification and detection of genomic DNA representing a somatic gene mutation from a cancerous tissue of interest.
Target Area Human tissue from known cancer patients, removed during biopsy procedures.
Review Panel Immunology
Product CodeOWD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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