Interpretive software IVDs

Intended purpose

A standalone in-vitro diagnostic software for qualitative and semi-quantitative discrimination, relative quantification and monitoring of donor-derived cell-free DNA in plasma from patients following kidney transplantation and/or monitoring of mixed chimerism from patients following hematopoietic stem cell transplantation (HSCT). . The software is intended for use with the One Lambda Devyser Accept cfDNA and/or One Lambda Devyser Chimerism. The software procedure is manual and is intended to be used by qualified laboratory professionals only.