Team-NB, the European Association of Medical Devices of Notified Bodies, published a position paper on the approach to the Technical Documentation assessment of multiplex IVD devices.
Multiplex in vitro diagnostic medical devices
Multiplex in vitro diagnostic medical devices are devices with more targets or markers (several allergens or bacteria) simultaneously detected in one common procedure. Usually, they can detect over 100 targets or markers.
Multiplex . . .
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