Description
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved, CLIA Waived
Contents: (20) Sealed Test Devices, (20) Assay Buffer, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Instructions for Use
Determinations: Detection of the SARS-CoV-2 IgG and IgM antibodies
Storage Requirements: 37° – 86° F
Processing Time: Approximately 15 Minutes
Fact-Sheet-Recipients
Fact-Sheet Provider
Package Insert
EUA Authorization Letter
The Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. The COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the presence of lgM 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 emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
- This product is not for home use (Emergency Use Authorization – In Vitro Diagnostic Use Only)
- Not for screening of donated blood
