FDA-Device2021-02-24Class II
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.
Sky Medical Supplies and Equipments LLC
Hazard
Distributed COVID test kits without emergency use authorization.
Sold states
Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Affected count
10,000 kits
Manufactured in
5987 Nw 102nd Ave, N/A, Doral, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2021Don't want to check this manually?
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