The US Food and Drug Administration last week granted Emergency Use Authorization for Premier Medical Laboratory Services' Diversified Medical Healthcare SARS-CoV-2 Assay.

The COVID-19 Antigen Home Test manufactured by Assure Tech has been validated by laboratory and clinical studies to meet FDA standards and has been granted EUA. This means that the product can be marketed in the USA and in countries that recognise FDA EUA approval.

The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for a molecular COVID-19/flu test from Lucira Health.

ANP Technologies has received Emergency Use Authorization from the US Food and Drug Administration for its NIDS COVID-19 Antigen Home Test, according to the agency said on Thursday.

The US Food and Drug Administration said on Tuesday that it has granted Emergency Use Authorization for Roche's molecular monkeypox test.

Roche has begun over-the-counter sales of its at-home COVID-19 rapid antigen test in the U.S.

The US Food and Drug Administration this week granted Emergency Use Authorization for Nanobiosym Precision Testing Services' Nano Test for COVID-19.

The US Food and Drug Administration last week granted Emergency Use Authorization for Rize Laboratory's SARS nCoV-2019 Multiplexed Assay.

Italian diagnostics firm DiaSorin said on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its Simplexa Congenital CMV Direct kit for the detection of cytomegalovirus (CMV) DNA.

Qiagen reported double-digit year-over-year sales growth in its core non-COVID-related product portfolio on Monday afternoon, prompting the company to raise its full-year guidance.