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Biocartis’ EGFR Mutation Test gains IVDR Class C CDx certification
Biocartis’ Idylla EGFR Mutation Test has secured the EU Technical Documentation Assessment and Quality Management System certificate, making it the first Idylla Test to achieve Class C companion diagnostic (CDx) in vitro medical device status. The post Biocartis’ EGFR Mutation Test gains IVDR Class C CDx certification appeared first on Medical Device Network.
Biocartis’ Idylla EGFR Mutation Test has secured the EU Technical Documentation Assessment and Quality Management System certificate, making it the first Idylla Test to achieve Class C companion diagnostic (CDx) in vitro medical device status.
The post Biocartis’ EGFR Mutation Test gains IVDR Class C CDx certification appeared first on Medical Device Network.
