SRDK0921_ Analytical Performance Study

CompletedOBSERVATIONAL
Enrollment

439

Participants

Timeline

Start Date

September 21, 2023

Primary Completion Date

September 29, 2023

Study Completion Date

September 29, 2023

Conditions
Kidney Transplant Rejection
Interventions
DEVICE

SRDK0921

SRDK0921 is an IVD composed of IVD kit for qPCR (SRDK0921KIT) and a cloud-based software (SRDK0921SOFT). It is a class C, rule 3k, IVD according to Regulation (EU) 2017/746.

Trial Locations (1)

44000

Nantes hospital, Nantes

Sponsors
All Listed Sponsors
collaborator

Nantes University Hospital

OTHER

lead

BioMAdvanced Diagnostics

INDUSTRY

NCT05747274 - SRDK0921_ Analytical Performance Study | Biotech Hunter | Biotech Hunter