The Cue Cell Processing system is for laboratory use only. Unless the user has obtained advance clearance or approval from the appropriate regulatory agency, cells processed on this system are not intended for diagnostic purposes, direct transfusion, or for use in the production of therapeutic products or vaccines for clinical use. For applications requiring regulatory clearance or approval, users may request technical documentation from Fresenius Kabi to support their submissions.
The Cue Cell Processing System, with use of Research Use Only (RUO) disposable product, is not for human use. Cells processed using the RUO set are not for production of a therapeutic product or vaccine, clinical use, or direct transfusion to a patient. The sterility of the RUO set pathway cannot be guaranteed.
Refer to the Cue Cell Processing System User's Guide for a complete list of warnings and precautions associated with the use of this product.
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