Device product
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Z-2381-2021
Product summary
- Event
- Event 88477
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 kits
- Official record key
device-enforcement:Z-2381-2021
Official wording
Reason: Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Code information: Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.
Distribution pattern: US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Derived failure modes
-
Unknown
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129