2025-09678Notice

FDA Pulls Plug on Four COVID Tests: Time to Switch

Published Date: 5/29/2025

Notice

Summary

The FDA is ending emergency use permissions for four COVID-19 test kits from Pfizer, MAWD Laboratories, and Nuclein (now part of Molecular Diagnostics). This means these specific tests can no longer be used under emergency rules, as the companies asked for it. If you use these tests, check for updates soon—this change could affect testing options but won’t cost you extra.

Analyzed Economic Effects

1 provisions identified: 0 benefits, 1 costs, 0 mixed.

Four COVID-19 Tests Lose Emergency Use

If you use one of these specific COVID-19 tests, they can no longer be used under the Emergency Use Authorization rules: Lucira COVID-19 All-In-One Test Kit; Lucira CHECK-IT COVID-19 Test Kit; MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR; and DASH SARS-CoV-2/S Test (Nuclein/Molecular Diagnostics). The companies asked the FDA to revoke the authorizations, so these tests may no longer be available under EUA and could change your local testing options, but the notice states this change will not cost you extra.

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Key Dates

Published Date
5/29/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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