Leica BOND Ready-to-Use ISH CMV Probe - HSA Registration DE0507323
Access comprehensive regulatory information for Leica BOND Ready-to-Use ISH CMV Probe 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 DE0507323 and owned by Leica Biosystems Newcastle Ltd. The device was registered on September 30, 2022.
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CMV Probe is intended to be used for the qualitative identification by light microscopy of human cytomegalovirus early gene RNA transcript in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes BOND-MAX, BOND-III, and BOND- PRIME systems). CMV Probe is recommended to identify CMV-expressing cells in patients suspected of CMV infection. CMV Probe is recommended for use on tissue specimens from patients with suspected CMV infection, as an adjunct to conventional histopathology using non- immunologic histochemical stains. CMV probe is optimized 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). This device is not intended for use in the detection of CMV in neonates.