Amniotic membrane is a distinct tissue source from the umbilical cord matrix PB supplies as Wharton's jelly products. PB does not offer an amniotic membrane product.
For any amniotic membrane product from another supplier, request the tissue source, processing description, sterility testing results and regulatory classification documentation for the specific format and lot under consideration.
Whether a specific intended use of any such product meets all applicable criteria in 21 CFR 1271.10, including minimal manipulation, homologous use and absence of a systemic effect, is a determination for the clinic and its counsel.
PB's catalog does not include amniotic membrane. If evaluating a separate product, confirm format-specific documentation rather than assuming uniformity across suppliers.