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QIAGEN gains CE-marking for in-vitro diagnostic kit and its automated testing platform NeuMoDx under new EU IVDR framework (Qiagen Press Release)
"QIAGEN N.V...today announced the certification of its leading in-vitro diagnostic (IVD) kit and its fully automated NeuMoDx platforms under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR) replacing the previous IVDD rules since May. The ipsogen JAK2 RGQ PCR Kit used for myeloproliferative neoplasms (MPN), a certain type of blood cancer, is now QIAGEN’s first IVD kit with IVDR CE-marking under Class C."
European regulatory
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Ipsogen JAK2 RGQ PCR Kit