PLASMA SCREENING
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 | LCO00792 | |
| Austrian Agency for Health and Food Safety (AGES) | INS-482518-13518398-16506783 | |
| Pennsylvania Department of Health | 25843A | |
| Therapeutic Goods Administration (TGA) | MI-2021-CE-01423-1 | |
| 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 | 05D0713514 | |
| CDC Permit | 20221104-4057A |
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 | |
| Therapeutic Goods Administration (TGA) | MI-2021-CE-01423-1 | |
| Maryland Department of Health | 1881 | No expiration |
| Rhode Island Dept. of Health License | LCO00791 |