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Press Release Biocartis NV: Biocartis Announces IVDR Class C CDx Certification of the Idylla™ ...

Summary by Hastings Tribune
PRESS RELEASE 02/06/2025, 10:00 CEST

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Press Release Biocartis NV: Biocartis Announces IVDR Class C CDx Certification of the Idylla™ ...

PRESS RELEASE 02/06/2025, 10:00 CEST

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Medical Device NetworkMedical Device Network

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.

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Hastings Tribune broke the news in on Monday, June 2, 2025.
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