Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.