Additional Information

Test was FDA Allowed on May 2, 2020. (EUA application #201535 currently under review)
(NOTE: There is a difference between Allowance and Approval. Test kit manufacturers must apply for FDA Approval. Granger Genetics is not a test kit manufacturer. Laboratories like Granger Genetics who are CLIA-accredited to perform complex testing do not apply for FDA approval of their tests. However, labs may voluntarily submit formal “Notice” to the FDA containing all their test validation data, and after the FDA accepts the Notice, the test is referred to as “Allowed”. Granger Genetics’ COVID-19 Antibody Tests are FDA Allowed.)

*Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
*Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
Scroll to top