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A) FFMU Methodologies
…FFMU products are tested using various in-house methodologies as part of routine batch release to ensure they meet internal quality specifications. These methods are not intended to imply validation for any specific diagnostic use. It is the customer’s responsibility to verify and validate the suitability of FFMU products with their…
Research Use Only (RUO) Products
A) RUO Product Table
…Research Use Only (RUO) Products: Lorne offers a range of antibody solutions designated for Research Use Only (RUO) or for other applications validated by the user. Any use beyond the intended purpose specified by the manufacturer is the sole responsibility of the end user. These solutions contain monoclonal…
A) FFMU Product Table
…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…
TUV SUD Surveillance Transfer Confirmation Letter - CLI 123789
/assets/client-files/pdfs/CLI_123789_0002_Rev._01_.pdf

