Licenses and Certifications

Licenses and Certifications

National Genetics Institute (NGI) is licensed as a clinical laboratory provider by both state and federal agencies. We participate in a number of approved quality control programs, including those operated by the College of American Pathologists (CAP). NGI actively collaborates with regulatory authorities and participates in standardization activities.

NGI holds active biologics license applications by the United States Food and Drug Administration (FDA) for UltraQual® HCV, HIV, and HBV assays and holds current good manufacturing practice (cGMP) certificates from various foreign regulatory authorities, including the Austrian Agency for Health and Food Safety.

NGI 2440 S. Sepulveda Blvd., Los Angeles, CA (Pre-PCR)

NGI Facilities Licenses/Certifications Number/Identifier Expiration
CAP Certification (Pre-PCR Facility) Jun 2018
California State Clinical Laboratory License Aug 2018
Clinical Laboratory Improvement Amendments Feb 2019
Austrian Agency for Health and Food Safety (AGES) Oct 2020
Florida State Clinical Lab Dec 2019
Pennsylvania Department of Health Aug 2018
Therapeutic Goods Administration (TGA) Feb 2018
FDA Blood Establishment Registration Dec 2018
New York Clinical Laboratory Permit Jun 2018
Maryland Department of Health Jun 2018
Rhode Island Clinical Lab LIcense Dec 2018
West Virginia Certificate for HIV/AIDS Related Testing Dec 2018

NGI 2311 Pontius Ave., Los Angeles, CA (Post-PCR)

NGI Facilities Licenses/Certifications Number/Identifier Expiration
CAP Certification (Post-PCR Facility) Jun 2018
California State Clinical Laboratory License Aug 2018
Clinical Laboratory Improvement Amendments Apr 2020
Austrian Agency for Health and Food Safety (AGES) Oct 2020
New York Clinical Laboratory Permit Jun 2018
Therapeutic Goods Administration (TGA) Aug 2018
FDA Blood Establishment Registration Dec 2018
Maryland Department of Health Jun 2020
Rhode Island Dept. of Health License  

Anatomical Pathology Services

NGI Facilities Licenses/Certifications Number/Identifier Expiration
CAP Accreditation Certificate Feb 2019
California State Clinical Laboratory License Mar 2018
Clinical Laboratory Improvement Amendments Apr 2019
Florida State Clinical Lab Aug 2018
Pennsylvania Clinical Laboratory Permit Aug 2018

FDA Approved Assays 

Assay Number (STN)
UltraQual® Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV BL 125658/0
UltraQual® HCV RT-PCR Assay
UltraQual® HCV v2 RT-PCR Assay BL 103868/5094
UltraQual® HIV-1 RT PCR Assay
UltraQual® HIV-1 v2 RT PCR Assay BL 103902/5089
UltraQual® HBV PCR Assay