Assure Fastep COVID-19 IgG/IgM Rapid Test Kit
Detection of IgG and IgM antibodies to aid in the diagnosis of COVID-19. The Assure Fastep COVID-19 IgG and IgM Rapid Test Kit is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood, serum, and plasma.
Chorus Trio Instrument & Assays
Multi-parametric analyzer for infectious diseases and autoimmunity testing with ready-to-use single test devices.
Enzywell SARS-CoV-2 lgA, lgM, and lgG
Antibody tests for lgA, lgM, and lgG to aid in the diagnosis of COVID-19. The Enzywell SARS-CoV-2 lgA, lgM, and lgG are immunoenzymatic methods for the qualitative determination of these antibodies to the SARS-CoV-2 virus in human serum.
Triturus ELISA Instrument
A completely open and fully automated ELISA analyzer for testing and processing batches of samples for biological drug monitoring.
This information is intended for physicians and healthcare professionals only.
Product registration and availability vary by country. For more information on product availability, please contact us here.
The Assure Fastep test kit has not been FDA cleared or approved; 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 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 emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Use of the Assure Fastep test kit with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. This test is also authorized for use with fingerstick whole blood specimens only 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.