FDA-Device2022-03-23Class I
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
SD Biosensor, Inc.
Hazard
Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.
Sold states
U.S. Nationwide Distribution
Affected count
~400,000 kits
Manufactured in
1556 Beon-Gil, Yeongtong, C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero, Suwon, N/A, Korea (the Republic of)
Products
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2022Don't want to check this manually?
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