Arrayit Corporation (ARYC)

[Alyssa]

Well, I-Man, speaking of perplexing (as of 9/4/20 FDA website), Arrayit is still NOT on this list.

Q: What commercial manufacturers of serological tests that had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests have now been removed from that notification list and should no longer be offering that test? (Updated 9/4)

The commercial manufacturers in the list below provided notification to the 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. The 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, the 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.

The FDA expects that the tests on this list will not be distributed unless and until an EUA is issued for the test, and the FDA may take additional actions as appropriate.

Recommendations for clinical laboratories and health care providers regarding these tests may be found in the FDA's June 19, 2020, Letter to Clinical Laboratory Staff and Health Care Providers.

Open this link for the list of 117 companies that are NOW NOT ALLOWED to use their tests. Arrayit is NOT ON THIS LIST.

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#nolonger