NGI

Certifications and Licenses

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 and HIV assays and holds current good manufacturing practice (cGMP) certificates from various foreign regulatory authorities including GHA.

California State Clinical Laboratory License
Clinical Laboratory Improvement Amendments (CLIA)
Florida State Clinical Lab License
German Health Authority (GHA)
New York Clinical Laboratory Permit
Pennsylvania Department of Health
Therapeutic Goods Administration (TGA)
FDA Biologics License UltraQual™ HIV
FDA Blood Establishment Registration
FDA Biologics License UltraQual ™ HCV

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