At present, six new COVID-19 antigen (home-use) kits have been authorized for emergency use by BfArM. The certification means that the product can be sold in German supermarkets, and local residents can use the product for self-testing.
As of February 20, 2021, FDA has urgently authorized 14 COVID-19 antigen tests, involving 11 companies: Abbott、Ortho、Quidel 、BD、LumiraDx、Access Bio、Princeton BioMeditech、Luminostics、Celltrion、Quanterix、Ellume.
SARS-CoV-2 Inactivated Vaccine (Vero cells) developed by Beijing Sinovac Biotech Co., Ltd was approved for marketing with conditions.
On November 25, 2020(Beijing time), the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Innovita Biological ' novel coronavirus Innovita 2019-nCoV Ab Test (Colloidal gold).
On Aug 7th, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology.
From July to September, eight Chinese in vitro diagnostic companies have successively obtained Emergency Use Authorization(EUA) issued by US Food and Drug Administration (FDA) .
FDA will not require developers to submit a premarket approval application, premarket notification or emergency use authorization for laboratory developed tests, the Department of Health and Human Services announced on August 19th.
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19.
The American Red Cross has begun testing all blood, platelet and plasma donations for COVID-19 antibodies.
P23 Labs has received Emergency Use Authorization for its coronavirus PCR test from the US Food and Drug Administration.
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