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Please Note: The current marketplace has become quite challenging, making it very difficult to secure inventory commitments, lead-times and reliable pricing. In fact, prices are literally changing by the day. As a result, once sourcing has been identified, it requires virtually immediate purchase orders to be placed—often with substantial prepayment. Because of the sourcing relationships we have established, current lead-time on most products is approximately 2 weeks.
These test have been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. These test are only authorized for the duration of the deliration 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 Act, 21 U.S.C. $360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. * The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19. Sold in counts of 25.