UniCel DxI Immunoassay Systems(Includes the UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Systems; and the UniCel DxC 660i,UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i Synchron Access Clinical Systems)An in vitro diagnostic device (IVD)

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