Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
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.
Roche, Abbott, Hologic, Cepheid, Others Gain 510(k) Clearances in February
The US Food and Drug Administration last month granted clearances for a preeclampsia risk test, respiratory disease tests, and a digital pathology system, among others.
Canada's Augurex Gets UK Conformity Authorization for Rheumatoid Arthritis Diagnosis, Management Test
The test measures a protein biomarker and can be used to diagnose and manage patients with the progressive autoimmune disorder.
Agilent Technologies Gains Expanded IVDR Certification for PD-L1 CDx
The test has been certified for use in the EU to help guide the treatment of early-stage non-small cell lung cancer and previously untreated advanced melanoma.
Beckman Coulter Diagnostics Clinical Chemistry, Immunoassay Analyzer Nabs FDA Clearance
The analyzer has a throughput of up to 800 clinical chemistry tests and 100 immunoassays per hour.
Feb 20, 2025
Feb 13, 2025