That's interesting. Tuxi just called me on the phone with that same question. I do find it interesting that the application date and revision date for their EUA aligns closely with the AXIM EUA application.
On July 17, 2020 based on your1 request, the Food and Drug Administration (FDA) issued an
Emergency Use Authorization (EUA) for emergency use of the Rapid COVID-19 IgM/IgG
Combo Test Kit pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act)
(21 U.S.C. §360bbb-3) for the qualitative detection and differentiation of IgG and IgM
antibodies to SARS-CoV-2 in human serum and acid citrate dextrose (ACD) plasma. Your
product was intended for use as an aid in identifying individuals with an adaptive immune
response to SARS-CoV-2, indicating recent or prior infection. Testing was 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.
On February 27, 2021, you requested to revise your EUA. Based on that request, and having
concluded that revising the July 17, 2020, EUA is appropriate to protect the public health or
safety under section 564(g)(2)(C) of the Act (21 U.S.C. § 360bbb-3(g)(2)(C)), FDA is reissuing
the July 17, 2020, letter in its entirety with the revisions incorporated.2 Pursuant to section 564
of the Act and the Scope of Authorization (Section II) and Conditions of Authorization (Section
IV) of this reissued letter, your product3 is now authorized for use consistent with the indication
described above.
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