Accreditations

Certified, accredited and licensed for clinical and regulated testing

ResearchDx, dba PacificDx and Custom Diagnostics, is CLIA certified, CAP accredited, ISO 13485:2016 certified and FDA registered, with state licenses for clinical testing.

Federal accreditation and quality

Laboratory and quality certifications

Select a certificate to view it full size.

CMS

CLIA Certificate of Accreditation

High-complexity clinical testing under the Clinical Laboratory Improvement Amendments.

CAP

College of American Pathologists

Certificate of Accreditation, the gold standard for laboratory quality.

ISO

ISO 13485:2016

Certificate of Registration for our medical device quality management system.

State licensure

State clinical laboratory licenses

Licenses that allow us to accept patient specimens from these states, in addition to CLIA coverage.

California

Clinical laboratory license

New York

NYS Department of Health permit

Pennsylvania

Clinical laboratory permit

Rhode Island

Clinical laboratory license

Need a copy of a certificate for vendor qualification or an audit? Contact us and we'll send the current documents.

Qualifying a laboratory partner?

We support supplier audits and quality agreements for sponsors and diagnostic partners.