DevicePMAs@therightstef:P050045_S000 / 0-4
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Approval for the top2a fish pharmdx kit. The device is indicated for: top2a fish pharmdx kit is designed to detect amplifications and deletions (copy number changes) of the top2a gene using fluorescence in situ hybridization (fish) technique on formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Deletions and amplifications of the top2a gene serve as a marker for poor prognosis in high-risk breast cancer patients. Results from the top2a fish pharmdx kit are intended for use as an adjunct to existing clinical and pathological information.
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