Regulatory information

Regulatory information

The NephroCheck test system is CE marked as follows:

  • NephroCheck test/VITROS NephroCheck test: CE marked (non-annex II/general/GIVD [others]).

  • Astute140 Meter: CE marked (non-annex II/general/GIVD [others]).

  • VITROS 3600 Immunodiagnostic System: CE marked (non-annex II/general/GIVD [others]).

  • VITROS 5600 Integrated System: CE marked (non-annex II/general/GIVD [others]).

Four manufacturer field safety notices for this technology were identified but have been resolved.