Arrayit Corporation (ARYC)

[StockDetective]

Thanks ScorpGirl.

“For serological test, manufacturers can notify FDA that they have validated their test and they can distribute in US before an EUA is authorized. However, any COVID-19 test without an Emergency Use Authorization (EUA) by the FDA becomes a high complexity test. In order to do COVID-19 testing without an EUA from the FDA, the testing lab must be a CLIA certified laboratory that meets regulatory requirements to perform high complexity testing under §§493.1441 through 493.1495 of the CLIA regulations.”

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