Regulatory & Quality Safety

The products offered by Amniox Medical are processed and preserved human Umbilical Cord and 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, minimally manipulated and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).

Healthy mothers may be considered eligible for placental donor status following elective Cesarean Section delivery, full informed consent, 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 (RNA-NAT)
  • HIV-1 & HIV-2 Antibody
  • HTLV I & II Antibody (HTLV I/II Ab)
  • Hepatitis B Surface Antigen (HBsAg)
  • Hepatitis B Core Antibody (HBcAb)
  • Hepatitis C Virus (HCV, RNA-NAT)
  • Hepatitis C Antibody (HCVAb)
  • Syphilis (RPR)
  • West Nile Virus (WNV)
  • Hepatitis B (NAT)

Amniox Medical products are tested for microbiological aerobic, anaerobic and fungal organisms by an independent CLIA certified lab. Our proprietary processing technology maintains the structural biological integrity of Amniox Medical products.