Roche announced on Thursday that two of its tests for Alzheimer's disease have received 510(k) clearance from the US Food and Drug Administration.
The US Food and Drug Administration this week granted Emergency Use Authorization to Diazyme Laboratories for a SARS-CoV-2 total antibody test.
Editor's note: Major adjustments have been made to China's COVID-19 control policies, according to a 10-point notice released by the National Health Commission on Wednesday. Below are some of the key changes, to help you keep up to date.
Thermo Fisher Scientific said on Wednesday that its SeCore CDx HLA Sequencing System was granted de novo classification by the US Food and Drug Administration as a companion diagnostic to Immunocore’s Kimmtrak (tebentafusp-tebn) therapy for uveal melanoma.
The US Food and Drug Administration on Tuesday expanded its library of guidance for monkeypox test developers by releasing two templates for development of antigen tests for monkeypox infection, following the publication earlier this year of a pair of templates for molecular test development.
On November 28th China Biologics public release said that the company's anti-neoconazole monoclonal antibody F61 nasal spray developed by the company was approved for clinical use.
Cue Health on Wednesday afternoon announced that revenues for the third quarter beat both Wall Street expectations and previous guidance from the firm.
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.
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