The Alegria Flash PR3 Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash PR3 kit. The performance characteristics of the Alegria Flash PR3 Control Kit have not been established for any other assays or instrument platforms.
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to proteinase 3 (PR3) in a clinical specimen.