A Big Step for CRISPR-Based SARS-CoV-2 Test
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Agency Continues Crack Down on Unauthorized COVID-19 Tests
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
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Agency Unveils Guidance for Full Approval of SARS-CoV-2 Tests
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Device Reclassification Order Opens 510(k) Pathway for HCV RNA and Antibodies Tests
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Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)
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