From the California Department of Public Health link you provided:
ARRAYIT CORPORATION License Type CDF License Description DEEMED STATUS - LICENSED LABORATORY FOR A NON-PHYSICIAN OFFICE LAB (POL) WITH FEDERAL CERTIFICATE OF ACCREDITATION (COA). Facility License CDF : DEEMED STATUS - LICENSED LABORATORY FOR A NON-PHYSICIAN OFFICE LAB (POL) WITH FEDERAL CERTIFICATE OF ACCREDITATION (COA). CLIA Number 05D2147467 License ID 349880 Facility Name ARRAYIT CORPORATION Facility Address 927 THOMPSON PLACE Facility Address2 Facility City SUNNYVALE Facility County SANTA CLARA Facility Zipcode 94085 Facility Zipcode+4 Facility State CA Telephone Number (408) 744-1331 Fax Number E-mail ARRAYIT@ARRAYIT.COM Laboratory Director First Name JULIE Laboratory Director Middle Name Laboratory Director Last Name TAGUCHI
“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.”