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 Expires
CAP Certification (Pre-PCR Facility) 4187301
California State Clinical Laboratory Certificate CDF 10226
Clinical Laboratory Improvement Amendments 05D0713514
Austrian Agency for Health and Food Safety (AGES) INS-482518-0002-001
Pennsylvania Department of Health 25843A
Therapeutic Goods Administration (TGA) MI-2016-CE-13016-1
FDA Blood Establishment Registration 1582
New York Clinical Laboratory Permit PFI 5828
Maryland Department of Health 1882 No expiration
Rhode Island Clinical Lab License LCO00792
West Virginia Certificate for HIV/AIDS Related Testing Certificate of Approval

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

NGI Facilities Licenses/Certifications Number/Identifier Expires
CAP Certification (Post-PCR Facility) 8753408
California State Clinical Laboratory Certificate CDF 322270
Clinical Laboratory Improvement Amendments 05D0935390
Austrian Agency for Health and Food Safety (AGES) INS-482518-0002-001
FDA Blood Establishment Registration 1582
New York Clinical Laboratory Permit PFI 7184
Therapeutic Goods Administration (TGA) MI-2017-CE-06256-1
Maryland Department of Health 1881 No expiration
Rhode Island Dept. of Health License LCO00791