FDA-Device2022-02-16Class I
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
E25Bio, Inc.
Hazard
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
Sold states
US Nationwide distribution in the states of MA, FL, and HI.
Affected count
73,300 units
Manufactured in
501 Massachusetts Ave, The Engine, Cambridge, MA, United States
Products
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2022Don't want to check this manually?
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