FDA-Device2022-05-11Class I
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
SML Distribution, LLC
Hazard
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Sold states
US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.
Affected count
209,450 units
Manufactured in
1500-1631 Lincoln Ave., N/A, tyrone, PA, United States
Products
Skippack Medical Lab 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-0944-2022Don't want to check this manually?
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