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Donor tissue is recovered using one of the safest recovery techniques and sterile equipment to minimize any bioburden contamination. Amniotic tissues are procured through a network of qualified and trained recovery partners, following stringent screening and recovery protocols in a highly controlled processing environment. All tissues are processed aseptically.
Safety
Communicable disease testing is performed by an FDA registered and Clinical Laboratory Improvement Amendments (CLIA Certified) laboratory. Donor blood sample is taken prior to or at the time of recovery and tested for HBsAg, HBcAb, HCVAb, HIV1/2 Ab, HCV NAT, HIV NAT, HBV NAT, RPR/STS, WNV, and HTLV I/II. Allografts are subjected to stringent USP testing prior to release.

References
1) Collection and characterization of amniotic fluid from scheduled C-section deliveries. Jan Pierce, Pam Jacobson, Eric Benedetti, et al. Cell Tissue Bank. 2016; 17: 413-425
2) Amniotic Fluid: Not Just Fetal Urine Anymore. Mark A Underwood, William M Gilbert, Michael P Sherman. Journal of Perinatology. 2005; 25: 341-348

 

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