For in vitro diagnostic use. See country-specific product labeling for regulatory status. Digital Country Specific Labeling HER2 (4B5) ALGO BREAST IVD uPath HER2 (4B5) image analysis, Breast PID00000378 09134425001 HER2 (4B5) algo breast IVD - 1.x uPath HER2 (4B5) image analysis, Breast Electronic Services Not Available Not Available 09076204001 HER2 (4B5) algo breast RUO - 1.x uPath HER2 (4B5) image analysis, Breast 07613336190418 Electronic Services Not Available Not Available The uPath HER2 (4B5) image analysis, Breast algorithm 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 neoplastic breast tissue. en