Arrayit Corporation (ARYC)

[kraki]

That test has nothing to do with Arrayit's test.
Serology tests like Arrayit's are on page 9, section D. (pdf page 12)
https://www.fda.gov/media/135659/download

There is no EUA required for the anti-body test, but there are limitations on interpretation of the diagnosis.

For a more determinative test an EUA could be sought.