Given the amount of tests that have required certification under the new system, the EU has staggered the grace periods for different classes of devices already holding CE-IVD marks obtained under the ...
In brief, LDTs are in vitro diagnostics (IVDs) that are intended for clinical use and are designed, manufactured, and used within laboratories that are certified under the Clinical Laboratory ...
The "Global IVD Raw Materials Market - Focused Insights 2024-2029" report has been added to ResearchAndMarkets.com's offering. The global IVD raw materials market is expected to reach a value of ...
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed ...
Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in ...
"We're proud to welcome CMC Medical Devices to the Registrar Corp family," said Raj Shah, CEO of Registrar Corp. "Together, we offer medical device manufacturers a single partner to navigate complex ...
Precision Dx Products include Twist Precision Prep and Enrichment Dx Kit, Twist Precision Exome Dx Panel and Twist Precision Exome Dx Kit SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Twist ...
WALTHAM, Mass. & SAN DIEGO--(BUSINESS WIRE)--Revvity, Inc. (NYSE: RVTY), today announced a strategic agreement to commercialize an in vitro diagnostic (IVD) workflow solution for neonatal sequencing, ...
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