IVDR
Bio-Rad Receives IVDR Certification for Infectious Disease Molecular Quality Controls
The firm's CT/NG Positive Run Control and STI Negative Run Control will be the first products CE-marked under IVDR.
MSInsight Nabs €1.6M in Seed Funding to Develop Microsatellite Instability Cancer Dx Software
The French cancer diagnostics startup plans to obtain regulatory approval for its MSIcare software as an in vitro diagnostic medical device for MSI cancers.
MRC Holland Gets CE-IVDR Certification for Spinal Muscular Atrophy Tests
The company has received certification under Europe's In Vitro Diagnostic Regulation for a number of tests recently.
MRC Holland Gets CE-IVDR Certification for Breast, Ovarian Cancer Syndrome Tests
The Amsterdam-based company recently received IVDR certification for other tests including one for phenylketonuria.
MRC Holland Gets CE-IVDR Certification for Imprinting Disorders Test
The test is designed to help diagnose Temple, Kagami-Ogata, and Russell-Silver syndromes.