FDA Ends Emergency Use for One COVID Test
Published Date: 8/15/2025
Notice
Summary
The FDA is ending the emergency approval for LumiraDx’s COVID-19 test because the company asked them to. This means the test can no longer be used for quick COVID-19 diagnosis. If you use or sell this test, you’ll need to stop soon, but no extra costs or penalties are mentioned.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
LumiraDx COVID Test Authorization Revoked
If you use or sell the LumiraDx SARS CoV-2 RNA STAR Complete test, you must stop: the FDA revoked its Emergency Use Authorization at the company's request, so that test can no longer be used for quick COVID-19 diagnosis.
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