Sienna™ COVID-19 IgG/IgM Rapid Antibody Test Kits FDA-EUA (Pallet)
FDA EUA authorized Sienna-Clarity COVID-19 IgG/IgM antibody test kit for SARS-CoV-2. The Sienna rapid test kit delivers a result in ten minutes and meets the minimum FDA performance thresholds for serology test kits. The Sienna test kit was independently validated at the Frederick National Laboratory for Cancer Research, a federally funded research and development center sponsored by the National Cancer Institute.
The Sienna test kit is 100% manufactured in Finland (with no components sourced from China) by a leading European in vitro diagnostics company called Salofa Oy. With a capacity of 1.2M kits/week, Salofa Oy is CE, ISO 13485:2016 and EC certified.