FDA-Device2022-05-04Class I
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC
Hazard
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Sold states
US Nationwide distribution.
Affected count
12,632 kits
Manufactured in
1 Evertrust Plz Ste 1207, Jersey City, NJ, United States
Products
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2022Don't want to check this manually?
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