|Alafair Biosciences Inc., of Austin, Texas||Versawrap Nerve Protector||Ultrathin, sutureless, bioresorbable hydrogel implant||For covering and protecting peripheral nerves when managing peripheral nerve injuries in which there has been no substantial loss of nerve tissue||Received 510(k) clearance from the U.S. FDA|
|Assure Tech (Hangzhou) Co. Ltd., of Hangzhou, China||Assure COVID-19 IgG/IgM Rapid Test Device||Serology test that uses fingerstick blood samples||Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2||Received expanded emergency use authorization from the U.S. FDA as the first point-of-care antibody test for COVID-19; was previously authorized for use by certain labs|
|Quadrant Biosciences Inc., of Syracuse, N.Y.||Clarifi COVID-19 Test Kit||Real-time RT-PCR, saliva-based test||Qualitative detection of RNA from SARS-CoV-2 in saliva swab specimens that are collected using the Oracollect•RNA (OR100) saliva collection device||Received emergency use authorization from the U.S. FDA|
|Vela Diagnostics Pte. Ltd., of Singapore||Virokey SARS-CoV-2 RT-PCR Test v2.0||Automated probe-based reverse transcription PCR test||Detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs||Received emergency use authorization from the U.S. FDA|
For more information about individual companies and/or products, see Cortellis.