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FDA Grants Emergency Use Authorization for Predicine COVID-19 Test

Jul 22, 2022 | staff reporter

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization for a molecular SARS-CoV-2 test from Predicine.

The Predicine SARS-CoV-2 RT-PCR Test is designed to detect viral nucleic acid in anterior nasal specimens collected dry from individuals with or without COVID-19 symptoms using the Predicine COVID-19 Collection Kit. The test is also authorized for use with samples collected at home and with pooled samples containing up to eight specimens.

The test may only be performed by Hayward, California-based Predicine, according to the FDA.

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Molecular Diagnostics
Infectious Disease
COVID-19
PCR
Regulatory News & FDA Approvals
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emergency use authorization
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