Certificates & Licenses

AlloSource maintains the appropriate registrations, licenses and accreditations as listed below:

AATB
AATB Certificate – Centennial, CO
AATB Certificate Extension Letter – Centennial, CO

CLIA
CLIA Certificate
CLIA Certificate Extension

FDA – HCT/P 
For current FDA Tissue Establishment Registration documents, please visit the FDA Public Query and search “AlloSource.”
FDA HCT/P Establishment Registration Expiration Date Explanation
FDA Registration – Buffalo, NY
FDA Registration – Centennial, CO
FDA Registration – Chicago, IL
FDA Registration – Cincinnati, OH
FDA Registration – Houston, TX
FDA Registration – Maryland Heights, MO
FDA Registration – San Diego, CA
FDA Registration – Tracy, CA

FDA – Medical Device
Establishment Registration
AlloFuse 510(k) – K071849
AlloFuse Plus 510(k) – K103036
ReConnex 510(k) – K170957
AceConnex 510(k) – K213046

Health Canada
Health Canada CTO Registration, exp. 2025

ISO
ISO 13485:2016, exp. 2026

State Licenses
California License – San Diego, CA
California License – Tracy, CA
California License – Centennial, CO
Florida License – Centennial, CO
Maryland License – Centennial, CO
New York License – Centennial, CO
New York License – Buffalo, NY

State Registrations
Delaware Registration
Illinois Registration – Buffalo, NY
Illinois Registration – Centennial, CO
Illinois Registration – Chicago, IL
Illinois Registration – Cincinnati, OH
Illinois Registration – Houston, TX
Illinois Registration – Maryland Heights, MO
Illinois Registration – San Diego, CA
Illinois Registration – Tracy, CA
Oregon Registration – Houston, TX
Oregon Registration – Buffalo, NY
Oregon Registration – Centennial, CO
Oregon Registration – Chicago, IL
Oregon Registration – Cincinnati, OH
Oregon Registration – Maryland Heights, MO
Oregon Registration – San Diego, CA
Oregon Registration – Tracy, CA

certificates