The FaStep Antibody Test Kit, granted an Emergency Use Authorization by the FDA on July 6, 2020, brings a rapid solution to inform you about the presence of antibodies created in response to exposure to the novel coronavirus, and ease the burden on emergency healthcare services around the country.
Clinical integrity is our foremost priority at Accuris Diagnostics. These antibody test kits are designed and manufactured by Assure Tech, with nearly eight years of history with the FDA bringing products to the US market for both point-of-care and over the counter use. To date, Assure Tech has successfully earned 71 approvals for lateral flow chromatographic immunoassays and other products.
This antibody kit has been internally validated by the manufacturer and by Accuris Diagnostics. Please find the results of all non-FDA clinical studies performed on the FaStep device below:
Shipped to you direct from our facility in South Carolina.
Leading Physician Testimonial
Dr. David M. Soria, MD, FAAEM
Utilize FaStep COVID-19 Antibody Test Kit to identify patients that carry SARS/COV-2 antibodies as the quarantines requirements begin to loosen around the country
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