DevicePMAs@therightstef:P040005_S005 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P040005_S005","sourcedb":"DevicePMAs@therightstef","sourceid":"P040005_S005","text":"Approval for the her2 fish pharmdx kit. The device is indicated for in vitro diagnostic use. The her2 fish pharmdx kit is a direct fluorescence in situ hybridization (fish) assay designed to quantitatively determine her2 gene amplification in formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue specimens and ffpe specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. 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