Master File
Letter Request

Master File Letter Request

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Use the form below to request a cross reference letter for our US FDA Master File for specific BioLife Solutions products to be used in your clinical application. This is not for regulatory submissions to regulatory agencies other than the US FDA.

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US FDA Master File Cross Reference Letter Request

Here is a list of product Master Files we have filed with the United States Food and Drug Administration (US FDA):

CryoStor®
HypoThermosol® FRS
BloodStor® 27 NaCI
Cell Thawing Media 0.9% NaCl
Cell Thawing Media 5% Dextrose
Stemulate® & Stemulate®-CP human platelet lysate
nLiven PR® human platelet lysate
T-Liven PR® human platelet lysate
CellSeal® Cryogenic Vials
CellSeal® CryoCase

You may request a cross-reference to our Master Files only if you intend to submit a filing to the US FDA. This is not for regulatory submissions to regulatory agencies other than the US FDA. After verification of your request, we will generate an authorization letter for your files and notify the US FDA of your request.

For support and documentation for using BioLife Solutions’ biopreservation media in clinical applications submitted to regulatory agencies outside the USA, please contact us via our Ask the Scientists page.

Ask the Scientists

Master FileLetter Request

How can we help you?

US FDA Master File Cross Reference Letter Request

Master File
Letter Request