Xpert ® Breast Cancer STRAT4 - ARCSA Registration dbf24e5a6483c1534bb08dcee63f34a1
Access comprehensive regulatory information for Xpert ® Breast Cancer STRAT4 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID dbf24e5a6483c1534bb08dcee63f34a1 and manufactured by CEPHEID. The device was registered on October 05, 2022.
This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.
IT IS A SEMI-QUANTITATIVE ASSAY BASED ON POLYMERASE CHAIN REACTION WITH QUALITATIVE CUT-OFF VALUES FOR ESTROGEN RECEPTOR MRNA (ESR1), PROGESTERONE RECEPTOR (PGR), HUMAN EPIDERMAL GROWTH FACTOR 2 (ERBB2/HER2) AND PROLIFERATION MARKER KI-67 (MKI67) ISOLATED FROM TISSUE OF INVASIVE BREAST CANCER FIXED IN FORMALIN AND INCLUDED IN PARAFFIN (FFPE).