Licensed, certified and accredited
DxTerity® operates a California State licensed, CAP-accredited, CLIA laboratory capable of performing clinical and pre-clinical studies in compliance with good laboratory practice (GLP) standards. Any lab developed tests whose intended use is for use in diagnostic purposes beyond the scope of our CAP-accredited, CLIA laboratory, will be submitted for regulatory clearance and/or approvals in accordance with current FDA Code of Federal Regulations, in addition to state and local requirements.
College of American Pathologists (CAP) Accreditation
CAP: 8680553 AU-ID: 1664134
CLIA Certificate of Accreditation March 2022-March 2026
05D2054007
ISO 13485:2016 & EN ISO 13485:2016
MD 638376
State of California License
CDF-00343579
State of Rhode Island License
LC001152
State of Pennsylvania License
36662
FDA EUA Authorization: DxTerity SARS-CoV-2 RT-PCR CE Test
Submission #: EUA202120
Granted by FDA: 8/28/2020