On April 29, 2019, CTS will begin performing Donor-Screen HLA® Class I and II testing on the Stratec Biomedical AG Gemini. This instrumentation change is necessary as Bio-Rad is discontinuing service on our existing QuickStep instrumentation.
Although the Immucor assay and sample requirements will remain the same, 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 will be available on the CTS website on 04/29/19.
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FDA Guidance titled “Further Testing of Donations that are Reactive on a Licensed Donor Screen...