Testing of Patient Sample or Reference Material Using Reference Method

Preferred Label : Testing of Patient Sample or Reference Material Using Reference Method;

Alternative definition : FDA: The investigation employed relevant empirical testing of a patient sample or reference material using an appropriate reference method 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 : CL526757;

Codes from synonyms : 4107;

Details

Origin ID

C139453;

UMLS CUI

C4528485;

Automatic exact mappings (from CISMeF team)
- Testing of patient sample or reference material using reference method [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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