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Tissue products

Amniotic fluid

Amniotic fluid is the fluid that surrounds a developing fetus during pregnancy. It is distinct from Wharton's jelly tissue, and PB's seven-product catalog does not include an amniotic-fluid product.

Amniotic fluid fills the amniotic sac and cushions the fetus throughout pregnancy. It comes from a separate tissue source than the umbilical cord matrix used in PB's Wharton's jelly products.

PB does not supply an amniotic-fluid product. For any amniotic-fluid product offered by another supplier, request the donor eligibility summary, processing description and regulatory classification documentation directly from that supplier.

If evaluating an amniotic-fluid product from any supplier, request the certificate of analysis, donor eligibility summary and sterility testing results for the specific lot rather than relying on general marketing descriptions of the tissue source.

PB's catalog does not include amniotic fluid. If evaluating a separate amniotic-fluid product, confirm lot-specific documentation rather than relying on category-level marketing claims.

Sources

  1. 21 CFR 1271.10 - Are my HCT/Ps regulated solely under section 361 of the PHS Act ↗eCFR