The application has been submitted for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver to commercially supply the LumiraDx Platform, including the LumiraDx instrument along with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test.
This submission also covers the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.
The LumiraDx SARS-CoV-2 Ag Ultra Test utilises the company’s advanced technology for identifying the SARS-CoV-2 presence.
It is designed to provide accurate results and is already marketed in Europe and several global markets.
LumiraDx Clinical Regulatory and Quality Global SVP Carol Adiletto-Francis said: “LumiraDx remains committed to delivering innovative diagnostic solutions that address critical healthcare needs.
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“The submission of this first 510(k) application represents a significant milestone in the company’s journey towards receiving FDA approval for the COVID Ultra Test.
“This also forms the foundation for additional submissions of other high-performing assays on the same platform, many of which are available in Europe and elsewhere and others which are in late stages of development.”
During the pandemic, the company secured various Emergency Use Authorizations (EUA) for its SARS-CoV-2 Ag tests.
In February this year, LumiraDx received the FDA EUA and the UK Health Security Agency (UKHSA) validation for a multiplex test for Covid-19 and influenza A and B.
Named LumiraDx SARS-CoV-2 and Flu A/B STAR Complete, the assay enables laboratories to rapidly detect and differentiate individuals with respiratory viral infections consistent with Covid-19.