Start with labeled identity
Begin with the exact tissue type, presentation, and storage class on the current insert. Catalog names help you find a SKU; they do not replace lot-linked identity.
Independent evaluations of commercial cord-tissue allografts have reported low cell counts and only rare viable stem cells. Precision Biologics does not represent these products as containing functional living stem cells or as stem cell therapies.
What the evidence posture allows
Ask whether any cell count, particle count, or factor panel is lot-specific, which method produced it, and whether it appears on the certificate of analysis you would receive.
Published papers can inform education but do not rewrite labeling or create FDA approval for a commercial SKU.
Documentation to request and file
Request the current insert, certificate of analysis format, donor eligibility summary approach, sterility testing description, and shipping instructions before the first purchase order.
At receipt, match lot ID, expiration, and shipper condition to the purchase order. Incomplete packs stay open—do not close them by assumption.
Regulatory review boundaries
Whether a specific intended use meets criteria discussed under section 361 and 21 CFR 1271.10 is a determination for the clinic and its regulatory counsel.
This page is general information for licensed healthcare professionals. It is not medical or legal advice and does not establish a permitted application.
Frequently asked questions
Does an analytical figure prove clinical performance?+
No. Analytical figures characterize a lot; they are not clinical endpoints.
Should we call these stem cell products?+
No. Precision Biologics does not market these items as stem cell therapies.
Can literature replace a COA?+
No. File literature separately from lot evidence.
Does this page determine how we may use products discussed under what are wharton's jelly allografts?+
No. Intended use remains with the ordering physician and clinic counsel.