Lumiradx submits first 510(k) application to the fda for covid ultra test

Lumiradx submits a traditional 510(k) 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 instrument, with the lumiradx sars-cov-2 antigen (ag) ultra test, and the lumiradx sars-cov-2 ag quality control swab kit. lumiradx submits a traditional 510(k) 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 instrument, with the lumiradx sars-cov-2 antigen (ag) ultra test, and the lumiradx sars-cov-2 ag quality control swab kit.
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