Testing of Patient Sample or Reference Material Using Competitor's Device

Preferred Label : Testing of Patient Sample or Reference Material Using Competitor's Device;

Alternative definition : FDA: The investigation employed relevant empirical testing of a patient sample or reference material using a competitor's device that is comparable to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.;

NCI Metathesaurus CUI : CL526756;

Codes from synonyms : 4108;

Details

Origin ID

C139454;

UMLS CUI

C4528486;

Automatic exact mappings (from CISMeF team)
- Testing of patient sample or reference material using competitor's device [ICD-11 Extension code]
Semantic type(s)
- Functional Concept [UMLS semantic type]
concept_is_in_subset
- CDRH Cause Investigation - Type of Investigation Terminology [NCIt concept]
- FDA Center For Devices and Radiological Health Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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