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.
Licenses and Certifications
- College of American Pathologists (CAP) Accreditation CAP: 8680553 AU-ID: 1664134
- Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation 05D2054007
- ISO 13485:2003 & EN ISO 13485:2012 MD 638376
- State of California License 05D2054007
- State of Maryland License 2623