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FDA Provides EUA to ...

16th June 2020  Content supplied by: PerkinElmer

PerkinElmer Receives FDA Emergency Use Authorization for EUROIMMUN COVID-19 RT-PCR Test


EUROIMMUN, a PerkinElmer Company, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its EURORealTime SARS-CoV-2 assay. Clinical laboratories, that are certified under Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests, can immediately begin using this RT-PCR test to detect SARS-CoV-2, the virus that causes COVID-19.

PerkinElmer now offers three FDA EUA solutions for COVID-19: the EURORealTime SARS-CoV-2 assay, the PerkinElmer Coronavirus Nucleic Acid Detection Kit and EUROIMMUN’s Anti-SARS-CoV-2 ELISA (IgG) serology test. For more details, please click here 

PerkinElmer’s comprehensive SARS-COV-2 offerings span RT-PCR, high throughput RNA extraction, automation, ELISA, and lateral flow-based serology testing.


    

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Date Published: 16th June 2020

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