Device product
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
Z-1127-2021
Product summary
- Event
- Event 87300
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,000 kits
- Official record key
device-enforcement:Z-1127-2021
Official wording
Reason: Distributed COVID test kits without emergency use authorization.
Code information: 2020042901
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Derived failure modes
-
Unknown
Distributed COVID test kits without emergency use authorization.