Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
Patients may show discrepant results when tested with the assay kit (value < lod or values < ldl) due to a nt-probnp genetic variant. as a consequence the manufacturer will update the method sheets accordingly in the limitations-interference section.