Leica BOND Ready-to-Use Primary Antibody Immunochemistry Antibody (Other Cancer Markers) - HSA Registration DE0510441
Access comprehensive regulatory information for Leica BOND Ready-to-Use Primary Antibody Immunochemistry Antibody (Other Cancer Markers) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510441 and owned by Leica Biosystems Newcastle Ltd. The device was registered on March 08, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The BOND MMR antibody panel is indicated for the detection of mismatch repair protein deficiency as an aid in the identification of hereditary nonpolyposis colorectal cancer (HNPCC)/Lynch Syndrome or sporadic CRC with MMR deficiency in patients diagnosed with CRC. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. Intended for use on the Leica Biosystems automated BOND-MAX, BOND-III or BOND-PRIME systems using the BOND Polymer Refine Detection kit (DS9800) or BOND-PRIME Polymer DAB Detection System (DS9284).