Leica BOND Ready-to-Use ISH Probe (FISH -Hematologic Disorder and Blood Cancer Markers) - HSA Registration DE0505841
Access comprehensive regulatory information for Leica BOND Ready-to-Use ISH Probe (FISH -Hematologic Disorder and Blood 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 DE0505841 and owned by Leica Biosystems Newcastle Ltd. The device was registered on June 03, 2021.
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Intended for use in the qualitative identification of light chain messenger RNA (mRNA) in formalin-fixed, paraffin embedded tissue by in situ hybridization (ISH) 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.