Regulatory & Quality Assurance

Restorative Therapies through 
Innate Integrity

Amniox Medical, Inc.

Regulatory & Quality Assurance

The products offered by AMNIOX® Medical are processed and preserved human Amniotic Membrane and Umbilical Cord. 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 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)

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.

Amniox Medical

  • 888-709-2140

Amniox® Medical is a wholly-owned subsidiary of TissueTech, Inc.

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