Assure Tech Fastep® COVID-19 IgG/IgM Rapid Test Device
The Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech. has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories operating minimally with a CLIA Certificate of Waiver. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
The point-of-care (POC)/waived/fingerstick Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech. is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma. In addition to CLIA moderate and high complexity laboratories, this test has been Emergency Use Authorized for use with fingerstick whole blood specimens at the point-of-care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is for professional use only. External controls sold separately.