Company Product Description Indication Status
Lumiradx UK Ltd., of London Lumiradx SARS-CoV-2 Ag test Antigen test For the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab specimens Received emergency use authorization from the U.S. FDA
Opgen Inc., of Gaithersburg, Md., and Curetis GmbH, of SARS-CoV-2 Kit with PULB Uses real-time reverse transcription polymerase chain reaction technology For the qualitative detection of SARS-CoV-2 isolated from oropharyngeal and nasopharyngeal swab specimens Obtained the CE mark certification
Pelvital USA Inc., of Minneapolis Flyte Noninvasive, intravaginal home-use device For strengthening of the pelvic floor muscles Received U.S. FDA clearance
Zymo Research Corp., of Irvine, Calif. Quick SARS-CoV-2 rRT-PCR Kit Uses real-time reverse transcription polymerase chain reaction technology For the qualitative detection of nucleic acids from SARS-CoV-2 in upper and lower respiratory specimens Granted the CE IVD mark

Notes

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

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