Preferred Label : Testing of Patient Sample Using Manufacturer's Device;
NCIt definition : Empirical testing of a patient sample using the device (usually an IVD) involved in
the reported adverse event or an identical device.;
Alternative definition : FDA: The investigation employed relevant empirical testing of a patient sample using
the device (usually an IVD) involved in the reported adverse event or an identical
device. Relevant testing would typically be based on test methods used for evaluating
safety and performance as described in the latest relevant standards.;
Codes from synonyms : 4123;
Origin ID : C217066;
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