Arrayit Corporation (ARYC)

[MikeCr]

A. the deletion list applies to commercial manufacturers.
B. ARYC is a laboratory, NOT a commercial manufacturer.
C. Per FDA guidance, laboratories are not required to submit an EUA request, but they may do so if they want.

What Tests Should No Longer Be Distributed for COVID-19?
Q: What commercial manufacturers of serological tests had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have now been removed from that notification list? (Updated 5/22)

The commercial manufacturers in the list below provided notification to FDA
that they validated and intended to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. FDA had previously included them on the website notification list of commercial manufacturers distributing serology test kits under that policy, but they have now been removed from that notification list and placed on the list below. As noted in the guidance, if an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from the notification list. Commercial manufacturers may also voluntarily withdraw their test notification, and such tests are noted with an asterisk.

(list of 29 commercial manufacturers)

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2