Certifications and Licenses | Discovery Life Sciences

Biocartis Partnership: Rapid Molecular Testing, U.S. and EU New Blog Post: Where to Look for cfDNA Discovery's Annual Year-End Sales Event is Here! Learn More.

Biocartis Partnership: Rapid Molecular Testing, U.S. and EU New Blog Post: Where to Look for cfDNA Discovery's Annual Year-End Sales Event is Here! Learn More.

Standards held across our global network

CAP Accredited CLIA Certified ISO 13485 FDA HCT/P Registered AABB Accredited ISO 15189 / IVDR

Discovery Life Sciences maintains accreditations from leading regulatory bodies across all sites. Our facilities are certified under CLIA, CAP, ISO 13485, and compliant with other relevant standards such as ISO 15189, enabling us to deliver reliable, high-quality results for research, clinical trials, and post-approval studies worldwide. Find our certifications and licenses organized by site below.

CAP College of American Pathologists — Genomics/FlowEffective 9/1/2026, CAP# 9588205 / CLIA# 01D2276829 was merged into CAP# 8833728 / CLIA# 01D2176350 and all US IHC services have been consolidated in Newtown. For more information, view the Accreditation Letter . View PDF

CLIA Clinical Laboratory Improvement Amendments — Genomics*New certificate in process View PDF CLIA Clinical Laboratory Improvement Amendments — Flow/IHC View PDF

CAP College of American Pathologists View PDF CLIA Clinical Laboratory Improvement Amendments View PDF ISO ISO 13485 — Quality Management System for Medical Devices View PDF

CAP College of American Pathologists View PDF CLIA Clinical Laboratory Improvement Amendments View PDF LDT LDT DeclarationIVDR-compliant services with Health Institution status of Discovery’s laboratory in Germany confirmed by German Regional Councils View PDF

IVDR IVDR Article 5(5) — Health Institution Designation Compliant with ISO 15189 · Lab-developed tests validated per CLSI guidelines Request Docs

CLIA Clinical Laboratory Improvement Amendments View PDF FDA FDA Registration — HCT/PsHuman Cells, Tissues, and Cellular and Tissue-Based Products View PDF AABB AABB AccreditationAssociation for the Advancement of Blood & Biotherapies · Expires Sep 30, 2026 View PDF CA California License — BiologicsExpires May 05, 2026 View PDF CA California License — Tissue BankExpires Jun 30, 2026 View PDF CA California License — Clinical Laboratory View PDF

CLIA Clinical Laboratory Improvement AmendmentsExpires Jun 20, 2026 View PDF FDA FDA Registration — HCT/PsHuman Cells, Tissues, and Cellular and Tissue-Based Products View PDF

Questions about compliance or documentation? Our quality team can provide additional certificates and answer regulatory questions.

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