The first FDA EUA, CLIA Waived COVID-19 Rapid Antibody Test (sold in boxes of 20 tests)
EUA CLIA Waived Finger-prick test. Results in 15 minutes.
The FaStep COVID-19 IgG/IgM Rapid Test is a rapid Point of Care Test intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood. The FaStep COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Each box contains 20 tests.
This test can only be administered by a licensed healthcare professional that has a CLIA certificate.
FDA Letter of Authorization (for the parent company, Assure Tech):
https://ec2392fc-d0b9-4daf-aa95-5f37a74e1b56.filesusr.com/ugd/b664d7_4d2b0d52a0134af6bf0df4eb5cf0acb4.pdf
NCL Report:
https://ec2392fc-d0b9-4daf-aa95-5f37a74e1b56.filesusr.com/ugd/b664d7_1da0d12a79cb4251a9d78fc4ce2ee07b.pdf
Fact Sheet for Healthcare Providers:
https://ec2392fc-d0b9-4daf-aa95-5f37a74e1b56.filesusr.com/ugd/b664d7_e27468a16d39447db46eba1b43248cd9.pdf
Fact Sheet for Healthcare Recipients:
https://ec2392fc-d0b9-4daf-aa95-5f37a74e1b56.filesusr.com/ugd/b664d7_b745a82a7d704081812d1558e5b1ee37.pdf
Instruction for Use:
https://ec2392fc-d0b9-4daf-aa95-5f37a74e1b56.filesusr.com/ugd/b664d7_63284c9cfe334c88bf2de7442c808278.pdf