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CTS quality
Gibco CTS products are manufactured at a site that uses methods and controls that conform with cGMP for medical devices, 21 CFR Part 820. Our FDA-registered manufacturing sites are ISO 13485– and ISO 9001–certified.
Accompanied by documentation to support your regulatory filing
Reduced risk from animal-origin materials and human-derived components
CTS B-27 Supplement XenoFree is formulated with only AOF recombinant components and human-derived components. To help reduce viral clearance risks, the use of human-derived components has been minimized and human-derived components are limited to materials that help meet regulatory standards for donor qualification, viral testing, and viral inactivation.