Device product
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
Z-0510-2021
Product summary
- Event
- Event 86798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 kits
- Official record key
device-enforcement:Z-0510-2021
Official wording
Reason: Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Code information: Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
Distribution pattern: US Nationwide distribution including in the states of IA, PA, WA.
Derived failure modes
-
Unknown
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests