emergency use authorization approved

Hymon SARS-CoV-2 Test Kit Authorized for Emergency Use

May 27, 2020

The FDA has granted an Emergency Use Authorization to SpectronRx for its Hymon SARS-CoV-2 test kit.

The polymerase chain reaction (PCR) test detects nucleic acid from the SARS-CoV-2 virus in upper respiratory specimens from individuals infected with COVID-19.  

The FDA said that all promotional materials relating to the use of the product must clearly state that the test has not been FDA cleared or approved and is for emergency use by authorized laboratories.

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