Device product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Z-0481-2022
Product summary
- Event
- Event 89315
- Status
- Completed
- Classification
- Class I
- Quantity
- 2100 units
- Official record key
device-enforcement:Z-0481-2022
Official wording
Reason: COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Code information: all lots
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.