Licenses and Certifications

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 licenses 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 GHA.

Licenses and Certifications (PDF)License/ID# Expires
FDA Biologics License UltraQual® HIVUSFDA1582..
FDA Biologics License UltraQual® HCVUSFDA1582..
FDA Biologics License UltraQual® HBVUSFDA1582..
NGI Sepulveda Facility (Pre-PCR)
CAP Certification (Pre-PCR Facility)4187301Jun 2018
California State Clinical Laboratory LicenseCLF10226Aug 2018
Clinical Laboratory Improvement Amendments05D0713514Feb 2019
Austrian Agency for Health and Food Safety (AGES)INS-482518-0002-001Oct 2020
Florida State Clinical Lab800011046Dec 2019
Pennsylvania Department of Health25843AAug 2018
Therapeutic Goods Administration (TGA)MI-2012-CE-04418-3Feb 2018
FDA Blood Establishment RegistrationFEI3003082450Dec 2018
New York Clinical Laboratory PermitPFI5828June 2018
Maryland Dept of Health1882Jun 2018
Rhode Island Clinical Lab LicenseLCO00792Dec 2018
West Virginia Certificate for HIV/AIDS Related Testing05D0713514Dec 2018
NGI Pontius Facility (Post-PCR)
CAP Certification (Post-PCR Facility)8753408Jun 2018
California State Clinical Laboratory LicenseCLF322270Aug 2018
Clinical Laboratory Improvement Amendments05D0935390Mar 2018
Austrian Agency for Health and Food Safety (AGES)INS-482518-0002-001Oct 2020
New York Clinical Laboratory PermitPFI7184June 2018
Therapeutic Goods Administration (TGA)MI-2012-CE-05972-3Aug 2018
FDA Blood Establishment RegistrationFEI3005037008Dec 2018
Maryland Dept of Health1881Jun 2018
Rhode Island Clinical Laboratory LicenseLCO00791Dec 2018
Anatomical Pathology Services
CAP Accreditation Certificate7191470Feb 2019
California State Clinical Laboratory LicenseCLF332531Mar 2018
Clinical Laboratory Improvement Amendments05D1037343Apr 2019
Florida State Clinical Lab800023913Aug 2018
Pennsylvania Clinical Laboratory Permit031681Aug 2018