Leica Bond Ready-to-Use Primary Antibody S-100 (EP32) - HSA Registration DE0505754
Access comprehensive regulatory information for Leica Bond Ready-to-Use Primary Antibody S-100 (EP32) 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 DE0505754 and owned by Leica Biosystems Newcastle Ltd. The device was registered on May 05, 2021.
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This reagent is for in vitro diagnostic use. S-100 (EP32) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of S-100B protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). 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.