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U.S. Department of Health and Human Services

Product Classification
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Device fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Definition Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.
Physical State Assay kit contains pre-treatment solution, TOP2A/CEN-17 probe mix, buffers, and fluorescence mounting medium
Technical Method Fluorescence in situ hybridization, manual method
Target Area Formalin-fixed, paraffin-embeded human breast cancer tissue specimen
Review Panel Pathology
Product CodeNXG
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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