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LumiraDx Submits First 510(k) Application to the FDA for COVID Ultra Test - Vimarsana News

LumiraDx Submits First 510(k) Application to the FDA for COVID Ultra Test

Published: June 30, 2023

LumiraDx submits a traditional 510 Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx...

Source: marketscreener.com
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City OfUnited KingdomUnited StatesCarol Adiletto FrancisDrug AdministrationLumiradx Limited NasdaqExchange CommissionDual SubmissionLumiradx PlatformLumiradx InstrumentQuality Control SwabEmergency Use AuthorizationsUltra TestClinical RegulatorySecurities Litigation Reform ActAnnual Report
LumiraDx Five-Minute SARS-CoV-2 Ag Ultra Test Achieves CE Marking - Vimarsana News

LumiraDx Five-Minute SARS-CoV-2 Ag Ultra Test Achieves CE Marking

Published: May 19, 2022

Results in just 5 minutes from sample application, aids in fast clinical decision-making at point of care (POC), helping to inform treatment decisions and...

Source: prnewswire.com
Related Topics:
United KingdomRon ZwanzigerColleen McmillenExchange CommissionHead Of The Division Biology PathologyMontpellier University Hospital CenterUltra TestChief Executive OfficerBiology PathologyLumiradx PlatformSecurities Litigation Reform ActAnnual ReportAsymptomatic Carriage AssociatedVariant Strain