Company Product Description Indication Status
Hologic Inc., of Marlborough, Mass. Panther Fusion SARS-CoV-2 assay Real-time RT-PCR in vitro diagnostic test for Hologic's Panther Fusion system For the qualitative detection of SARS-CoV-2 Received expanded emergency use authorization from the U.S. FDA for testing of individuals without symptoms or other reasons to suspect COVID-19 infection
Masimo Corp., of Irvine, Calif. Rad-G Pulse Oximeter Hand-held device with rechargeable battery Provides SET pulse oximetry, respiration rate from the pleth (RRp), and other vital parameters for both spot-checking and continuous monitoring Received U.S. FDA clearance
Quotient Ltd., of Eysins, Switzerland Mosaiq COVID-19 Antibody Microarray Serology test for both IgM and IgG antibodies Detects antibodies generated in humans in response to the SARS-CoV-2 virus Received emergency use authorization from the U.S. FDA
Zymo Research Corp., of Irvine, Calif. DNA/RNA Shield reagent and collection devices Sample collection and preservation devices For collecting specimens for diagnostics Received the CE mark for in vitro diagnostic applications

Notes

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