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stervc

12/11/20 12:42 PM

#5552 RE: elks #5542

With the MJTV COVID-19 Test Kits...

The test kits are approved by the FDA for Emergency Use Authorizations. (EUA) to get information on the Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices that CDRH has issued related to COVID-19: for more information about the kits please go to

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices | FDA
https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices

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Sterling