FDA issued an EUA COVID-19 genesig Real-Time PCR
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Posted On: 03/22/2020 9:14:01 AM
FDA issued an EUA COVID-19 genesig Real-Time PCR
https://novacyt.com/about-novacyt-group/
On March 20, 2020, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use the Primerdesign Ltd.’s Primerdesign Ltd COVID-19 genesig Real-Time PCR assay for the qualitative detection of SARS-CoV-2 nucleic acid in oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). The Primerdesign Ltd COVID-19 genesig Real-Time PCR assay is for use only under EUA in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
https://www.fda.gov/medical-devices/emergency...orizations
https://www.fda.gov/media/136306/download
https://novacyt.com/about-novacyt-group/
On March 20, 2020, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use the Primerdesign Ltd.’s Primerdesign Ltd COVID-19 genesig Real-Time PCR assay for the qualitative detection of SARS-CoV-2 nucleic acid in oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). The Primerdesign Ltd COVID-19 genesig Real-Time PCR assay is for use only under EUA in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
https://www.fda.gov/medical-devices/emergency...orizations
https://www.fda.gov/media/136306/download
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