Operating at the highest
standards.
FDA Registered & Inspected
BioXtek is an FDA registered and inspected facility, processed and distributed in full compliance with cGMP and cGTP.
- Registered under FDA 21 CFR Part 1271
- Compliant with 361 HCT/P regulations
- Registered with FDA Cosmetics Direct
AATB Accredited
Full accreditation from the American Association of Tissue Banks (AATB), signifying our commitment to the highest level of safety and ethical standards in the industry.
National Standard for Tissue Banking Excellence
HCT/P Regulatory Framework
Homologous Use
Our products are intended for homologous use only, acting as a protective barrier or cover to support the body's natural repair mechanisms.
Minimal Manipulation
BioXtek's BioPür® process ensures minimal manipulation of the structural properties of the original human tissue, preserving native ECM proteins.
Terminal Sterilization
All finished allografts undergo terminal sterilization via validated irradiation to achieve a Sterility Assurance Level (SAL) of 10⁻⁶.
Cosmetic Regulatory Framework
MoCRA Compliance
Ensures adherence to the Modernization of Cosmetics Regulation Act requirements, including facility registration, product listing, and adverse event reporting. This establishes a structured regulatory foundation aligned with current FDA expectations for cosmetic safety and transparency.
Cosmetic Good Manufacturing Practices
Implements standardized processes to ensure products are consistently produced and controlled according to quality standards, focusing on contamination prevention, proper documentation, and personnel training.
Safety Tested
The safety of our cosmetic products has been substantiated through sterility and endotoxin testing, and reviewed by a qualified medical professional.
Licenses & Certificates
FDA Registration 2026
AATB Accreditation Certificate
Delaware State Approval
Oregon Tissue Registry
California License
Illinois Tissue License
Maryland License
New York Certificate
Regulatory Notice: BioXtek makes no marketing claims regarding the safety or efficacy of its 361 HCT/P products. Use of these products is at the discretion of the licensed physician.