Device product
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Z-2452-2021
Product summary
- Firm
- Cellex
- Event
- Event 88206
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Approximately 44,821 kits
- Official record key
device-enforcement:Z-2452-2021
Official wording
Reason: The kit does not have an emergency use authorization (EUA).
Code information: All lot numbers
Distribution pattern: US Nationwide distribution in the states of CA, FL, TX, and WI.
Derived failure modes
-
Unknown
The kit does not have an emergency use authorization (EUA).