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Clinical Trial Summary

Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)


Clinical Trial Description

It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection. The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD). The SRDK0921 system (kit and software) is intended: - to calculate a score of subclinical rejection in kidney transplant patients - as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05747274
Study type Observational
Source BioMAdvanced Diagnostics
Contact
Status Completed
Phase
Start date September 21, 2023
Completion date September 29, 2023

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