FDA-Device2021-09-22Class II
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Cellex
Hazard
The kit does not have an emergency use authorization (EUA).
Sold states
US Nationwide distribution in the states of CA, FL, TX, and WI.
Affected count
Approximately 44,821 kits
Manufactured in
507 Airport Blvd Ste 107, N/A, Morrisville, NC, United States
Products
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2452-2021Don't want to check this manually?
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