FDA EUA Authorized COVID-19 IgG/IgM Rapid Test Cassette
FDA Emergency Use Authorization (EUA)
To be performed in a CLIA Moderate or high Complexity setting
Shelf life up to 24 months from the manufacture date
This test has received EUA authorization from the FDA. Health care professionals are permitted by the FDA to use this test device under the Emergency Use Authorization (EUA) regulations and manufacturer submission, provided those administering and using the test device comply with the conditions stated above and provided the tests are administered by health care professionals in Medium and High Complexity Labs.
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