Specifications
- Listed presentation
- EV preparation; listed 180B particles/mL
- Account access
- Licensed clinics and physician-supervised practices; request account verification
- Purchase review
- Request current label, composition, lot records, and handling instructions
Presentation and scope
The supplier describes a cord-blood-derived extracellular vesicle/exosome preparation and lists 180 billion particles per mL. The concentration is a supplier-listed analytical figure, not an independently verified count or a clinical performance measure.
Keep the product name, size, and revision of the supplied label together in the purchasing file. A catalog description helps identify an item; it does not replace the documentation for the lot being considered.
Read analytical figures in context
Request the method, reporting units, sample preparation, and lot identifier behind any particle or constituent measurement. A figure per mL cannot be compared directly with a figure per formulation without the relevant volume and preparation information.
The supplier describes characterization methods for Bio Xsomes including nanoparticle tracking analysis, ELISA, single-particle imaging, and marker identification. Request the applicable reports rather than assuming those methods or findings apply across the catalog.
Lot review before receipt
The supplier describes unique lot identification, third-party sterility testing, and quarantine until testing and internal release criteria are complete. Ask which records apply to the product and lot in your order.
Request a certificate of analysis, the applicable donor eligibility summary, release status, expiration information, and the current insert. Record any unavailable document as an open item for your clinic’s purchasing reviewer.
Receiving and storage review
Confirm the product-specific storage and shipping instructions before booking delivery. Do not infer frozen or shelf-stable handling from the vial size, product family, or another item’s instructions.
Assign a receiving contact, check the vial and shipping records against the purchase order, and preserve the lot identifier in inventory. If labeling or handling records disagree, hold the item for a written supplier disposition before any release decision.
Intended use belongs in a separate review
For licensed clinic procurement. This is not a stem cell therapy. No clinical outcome is represented. The ordering physician and clinic counsel must review the current labeling, product classification, and intended use before any purchase or use decision. Account verification does not establish permission for a clinical application.
A tissue format, analytical panel, or account approval does not establish a permitted application. Route unresolved labeling and regulatory questions to clinic counsel rather than using a catalog description as a clinical protocol.
Frequently asked questions
What should our purchasing team request?+
Request the current label, lot-specific analysis, applicable donor eligibility summary, release record, expiration details, and handling instructions. Confirm document availability before ordering.
Does the listed format establish an intended use?+
No. Presentation and analytical specifications do not establish a permitted application. The physician and clinic counsel review intended use separately.
Can patients purchase this product?+
Accounts are for licensed clinics, physicians, and practices operating under physician supervision. Contact Precision Biologics for account verification.