VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody - Immunohistology cell marker IVDs
Access comprehensive regulatory information for VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody - Immunohistology cell marker IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Ventana Medical Systems Inc in United States of America. The device registration started on February 14, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody is intended for use in the assessment of mismatch repair (MMR) protein PMS2 in formalin-fixed, paraffin-embedded tissue specimens stained on a VENTANA BenchMark ULTRA and BenchMark ULTRA PLUS instrument. This antibody is one of the components of VENTANA MMR RxDx Panel that is indicated as an aid in identifying patients eligible for treatment with pembrolizumab in deficient MMR solid tumours, and a combination of pembrolizumab and lenvatinib in proficient MMR endometrial carcinoma.