Leica BOND Ready-to-Use Primary Antibody Mammaglobin (EP249) - HSA Registration DE0510604
Access comprehensive regulatory information for Leica BOND Ready-to-Use Primary Antibody Mammaglobin (EP249) in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510604 and owned by Leica Biosystems Newcastle Ltd. The device was registered on April 17, 2025.
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Mammaglobin (EP249) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human mammaglobin protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). Mammaglobin (EP249) is recommended to identify cells originating from breast or exhibiting mammary differentiation. 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. Mammaglobin (EP249) is recommended for use on tissue specimens from patients with suspected lesions of the breast, as an adjunct to conventional histopathology using non-immunologic histochemical stains.