Stat-Technologies (Golden Valley, MN) announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for the COVID-19 IgG/IgN rapid test kits it carries. The tests offered by Stat-technologies are manufactured by Healgen Scientific.
According to the company, the FDA authorization and Preferred-Provider status allows Stat-Technologies to have an ample supply of test kits for medical professional use and to take orders immediately for July delivery.
The COVID-19 IgG/IgM Rapid Test kits provide results in just 10 minutes and are designed for use with whole blood, serum or plasma samples. With a high degree of accuracy, the kits detect IgM that may appear in blood within 3-5 days following incubation and IgG that appears as soon as 1-2 weeks.
The tests are authorized for use in high or moderately complex CLIA laboratories and must be administered by a medical professional. The kits have a shelf life of 24 months from the date of manufacture and can be stored at room temperature or in a refrigerator.
Stat-Technologies said it will have access to enough tests to satisfy both existing pre-orders and future orders.