For Further Manufacturing Use (FFMU) Products

For Further Manufacturing Use (FFMU) Products: Lorne offers a range of Bulk FFMU products designed for use in the production of Immunohematology In Vitro Diagnostic Medical Devices (IVDMDs). These products contain relevant red cell monoclonal and/or polyclonal antibodies (where applicable) and are supplied in an optimally diluted buffer solution. Lorne’s FFMU products do not contain or consist of CMR substances or endocrine-disrupting substances that could cause sensitization or allergic reactions. Additionally, all FFMU products have undergone comprehensive stability studies, including shelf-life and transportation testing, to ensure product integrity and reliability. Our customers may repack, relabel, and release these products under their own brand, assuming full manufacturer responsibility for compliance with all applicable regulatory requirements before placing them on the market. For added flexibility, Lorne Laboratories Ltd also offers custom manufacturing support, helping clients with additional production processes as needed.

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