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Kwokman Dx Gets FDA EUA for SARS-CoV-2 Molecular Testing Sample Collection Kit

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Kwokman Diagnostics' at-home nasal swab specimen collection kit for SARS-CoV-2 testing.

The Kwokman Diagnostics COVID-19 Home Collection Kit is designed for the at-home self-collection of anterior nasal swab specimens for use with in vitro diagnostics that detect SARS-CoV-2 RNA. The kit is for use by individuals at least 18 years old.

Testing of samples collected with the kit is limited to labs CLIA-certified to perform high-complexity tests and designed by Irvine, California-based Kwokman, according to the FDA.