Leica Bond Ready to Use Primary Antibody Human Chorionic Gonadotrophin (Polyclonal) - HSA Registration DE0507155
Access comprehensive regulatory information for Leica Bond Ready to Use Primary Antibody Human Chorionic Gonadotrophin (Polyclonal) 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 DE0507155 and owned by Leica Biosystems Newcastle Ltd. The device was registered on August 10, 2022.
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Human Chorionic Gonadotrophin (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human chorionic gonadotrophin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an 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.