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Regulatory DocumentationFDA Establishment Registration
Official FEI Registration and HCT/P Listing for Quantum Cell Factor under 21 CFR 1271.
Registration Summary
This document provides the official FDA Establishment Registration and HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products) Listing for Cell Factor manufactured by Cellestiq Lab, LLC. The registration confirms compliance with 21 CFR 1271.10 for human cells, tissues, and cellular and tissue-based products.
Key Registration Details
FEI Number
3038417759
Last Registration Year
2025
Regulatory Classification
21 CFR 1271
PHS Act Section
361
Manufacturer Information
Legal Name
Cellestiq Lab, LLC
Product Name
Cell Factor
Location
13301 North Meridian Avenue, Ste 704B
Oklahoma City, Oklahoma 73120, USA
Reporting Official
Carlo Ledesma
Chief Scientific Officer
Establishment Functions
The establishment is registered to perform the following functions for Cell Factor:
Process
Store
Label
Distribute
Important Notice
FDA acceptance of an establishment registration and HCT/P listing does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by FDA (21 CFR 1271.27(b)).