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Restricciones en los EE.UU.: para cribado sanguíneo en los EE. UU./centros de transfusión:

• La interfaz del middleware del LIS solo se puede utilizar en el Instrument Manager fabricado por Data Innovations Llc. (conforme a la sección 510(k)).
• El producto debe utilizarse en modo autónomo (sin conexión física a sistemas automáticos ni a dispositivos de clase II).

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