Australia TGA ARTG recordVENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody - Immunohistology cell marker IVDs
Australia TGA ARTG Registered Device · Roche Diagnostics Australia Pty Limited · Ventana Medical Systems Inc · Class IIb · Started February 14, 2024
Good Name: Roche Diagnostics Australia Pty Limited - VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody - Immunohistology cell marker IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- February 14, 2024
- Effective Date
- February 14, 2024
- Country
- United States of America
- Address
- 1910 E Innovation Park Drive, Tucson, AZ, 85755
VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody is intended for use in the assessment of mismatch repair (MMR) protein MLH1 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.
Access comprehensive regulatory information for VENTANA anti-MLH1 (M1) 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.
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