CTS successfully implemented Donor-Screen HLA® Class I and II testing on the Stratec Biomedical AG Gemini on Monday, April 29th. As previously communicated, the Immucor assay and sample requirements are the same, and the package insert has been modified to state the assay is specific to the Stratec Gemini instrument. The new package insert, assay history list, and platform history list are now available on our website.
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FDA Guidance titled “Further Testing of Donations that are Reactive on a Licensed Donor Screen...