On June 30, 2023, LumiraDx Limited made a groundbreaking move by submitting its first 510(k) application to the U.S. Food and Drug Administration (FDA). This application sought clearance for the revolutionary LumiraDx 5-minute COVID Ultra Test.
The comprehensive submission included the LumiraDx Platform, the LumiraDx Instrument, the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit. These components work together seamlessly to deliver accurate and reliable results in a matter of minutes.
The LumiraDx SARS-CoV-2 Ag Ultra Test has already made its mark in Europe and various international markets. Its exceptional accuracy and reliability have instilled confidence in healthcare professionals and patients alike. Throughout the pandemic, LumiraDx had received Emergency Use Authorizations (EUA) for its SARS-CoV-2 Ag tests, solidifying its reputation as a trusted provider of diagnostic solutions.
This 510(k) submission marks a significant milestone for LumiraDx as it is the first time the LumiraDx Instrument has undergone such a review. It demonstrates LumiraDx’s unwavering commitment to delivering a complete solution that meets the highest standards of performance and safety. Once this submission is reviewed, it will pave the way for future submissions to the FDA, with a focus on the assay components.
The LumiraDx SARS-CoV-2 Ag Test is a cutting-edge microfluidic immunofluorescence assay designed to detect the presence of the nucleocapsid protein antigen in nasal and nasopharyngeal swabs. Leveraging LumiraDx’s advanced technology, the SARS-CoV-2 Ag Ultra Test sets a new standard for diagnostic accuracy and reliability. In just five minutes, it enables healthcare professionals to conduct accurate and confident testing on a larger scale.
https://beststocks.com/lumiradx-submits-510k-application-for-revolut/
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