FDA-Device2022-05-18Class I
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Woodside Acquisitions Inc.
Hazard
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Sold states
US distributions to states of: AL and GA.
Affected count
17,000 units
Manufactured in
1625 Lincoln Ave., N/A, tyrone, PA, United States
Products
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1045-2022Don't want to check this manually?
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