For in vitro diagnostic use. See country-specific product labeling for regulatory status. Digital Country Specific Labeling HER2 (4B5) ALGO BREAST IVD HER2 (4B5), breast cancer algorithm by navify® Digital Pathology PID00000378 09 134 425 001 9 134 425 001 09134425001 9134425001 09134425001 HER2 (4B5) algo breast IVD - 1.x uPath HER2 (4B5) image analysis, Breast Electronic Services Not Available Not Available 09 076 204 001 9 076 204 001 09076204001 9076204001 09076204001 HER2 (4B5) algo breast RUO - 1.x uPath HER2 (4B5) image analysis, Breast 07613336190418 Electronic Services Not Available Not Available The HER2 (4B5), breast cancer algorithm by navify Digital Pathology is an adjunctive computer-assisted tool that identifies HER2 on tumor cell membranes within a pathologist-annotated viable tumor region in images of formalin-fixed, paraffin- embedded invasive breast cancer tissue. en

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