Tissue Safety and Quality Assurance

The products offered by  Bio-Tissue® (PROKERA®, AmnioGraft®, & AmnioGuard®) are cryopreserved human Amniotic Membrane. They are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), minimally manipulated and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).

Live, healthy mothers may be considered eligible for placental donor status following elective Cesarean Section delivery. These mothers provide full informed consent and are put through extensive social habit screening, medical history and records review for infectious, malignant, neurological, auto-immune, transmissible diseases, and independent, serological CLIA lab testing (using FDA licensed test kits) which are non-reactive (negative) for the following tests:

  • HIV 1 & HIV 2, Antibody
  • HIV 1 Virus (NAT)
  • Hepatitis B surface antigen (HBsAg)
  • Hepatitis B core antibody (HBcAb)
  • Hepatitis C Antibody (HCVAb)
  • Hepatitis C Virus (NAT)
  • HTLV 1 & 2 antibodies
  • Syphilis (RPR)
  • Additional testing may include: West Nile Virus, WNV, (NAT)
  • Additional testing may include: Chagas (T. Cruzi)

FDA Registrations

AATB Accreditations

Tissue Bank Licenses

ISO Certifications

FDA Registration - Kendall, FL

AATB Accreditation

CA TB License - Doral

AHCA Waiver of Certification of Tissue Bank - Florida

ISO 9001:2008 Certification

FDA Registration - Doral, FL

CA TB License - San Diego

ISO 13485:2003 Certification

FDA Registration - CA

CTO Certificate - Canada

ISO 13485:2016 Certification

Illinois State License

Maryland TB License 

New York State License - Kendall, FL

New York State License - Doral, FL

New York State License - CA

Oregon State License - Kendal

Oregon State License - Doral

Oregon State License - CA