Company Product Description Indication Status
Chromacode Inc., of Carlsbad, Calif. HDPCR SARS-CoV-2 assay Real-time PCR-based molecular test For the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs as well as nasal aspirate, nasal wash, and bronchoalveolar lavage specimens Received emergency use authorization from the U.S. FDA
Illumina Inc., of San Diego Illumina COVIDSeq test First COVID-19 test to use next-generation sequencing technology; delivers sample receipt to result in 24 hours using the Novaseq 6000 sequencing system For the qualitative detection of SARS-CoV-2 RNA from nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, midturbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and bronchoalveolar lavage specimens Received emergency use authorization from the U.S. FDA
Quidel Corp., of San Diego Sofia SARS Antigen FIA Rapid point-of-care test For the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimens Received emergency use authorization from the U.S. FDA for use on the Sofia Fluorescent Immunoassay Analyzer (Sofia 1), Quidel's first-generation instrumented system; previously received authorization to run on the second-generation Sofia 2 instrumented system

Notes

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

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