COVID-19 Real-Time PCR assay EUA (USA)

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FOR US ONLY
Rapid detection and exclusive to the COVID-19 strain
Does not detect other related coronavirus strains
High priming efficiency
Accurate controls to confirm extraction, and assay validity
Lyophilised components for ambient shipping
Highly specific detection profile
This test has been authorized by FDA under an EUA for use by authorized laboratories.

Detail

This test has been authorized by FDA under an EUA for use by authorized laboratories.

Description

PrimerDesign-EAU-image

The Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

*FDA clinical study. See Instructions for Use for additional clinical data.

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