FDA-Device2022-05-18Class I
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
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
34,240 units
Manufactured in
1625 Lincoln Ave., N/A, tyrone, PA, United States
Products
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1044-2022Don't want to check this manually?
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