Recently, Wondfo Biotech's wholly-owned subsidiary in the United States, Wondfo USA Co., Ltd. (hereinafter referred to as the " Wondfo USA"), received notification from the U.S. Food and Drug Administration (FDA) that the WELLlife™ COVID-19/Influenza A&B Test has been granted Emergency Use Authorization (EUA240004). The WELLlife™ COVID-19/Influenza A&B Test is designed for professional use at the point-of-care (POC) settings.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox. The test is the first mpox at-home collection kit authorized by FDA and is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.

The US Food and Drug Administration said Thursday that it has granted Roche Emergency Use Authorization for a new version of its multiplex molecular assay for detecting SARS-CoV-2 and influenza A/B.

The US Food and Drug Administration this week released its guidance document for developers of medical devices for COVID-19, including diagnostic tests, on how to transition from Emergency Use Authorization to full marketing and regulatory authorization.

Cue Health announced on Monday that it has received Emergency Use Authorization from the US Food and Drug Administration for its molecular monkeypox test.

The US Food and Drug Administration said on Friday evening that it has issued an Emergency Use Authorization for Lucira Health's Lucira COVID-19 & Flu test, the first over-the-counter, at-home diagnostic test that can differentiate and detect influenza A and B, as well as SARS-CoV-2.

The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Mologic's over-the-counter SARS-CoV-2 antigen test.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Xpert Mpox test from molecular diagnostics company Cepheid.

The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Anavasi Diagnostics' molecular point-of-care AscencioDx COVID-19 Test Kit.

LumiraDx said Monday that it had nabbed US Food and Drug Administration Emergency Use Authorization and UK Health Security Agency Coronavirus Test Approvals process validation for LumiraDx's laboratory-based multiplex test for COVID-19 and influenza A and B.