Regulatory information

Regulatory information

The RIDASCREEN tests are CE marked as in vitro diagnostic devices. The manufacturer R-Biopharm has current CE certification for the following RIDASCREEN tests:

  • RIDASCREEN IFX Monitoring test (CE marked in September 2016)

  • RIDASCREEN Anti‑IFX Antibodies test (CE marked in February 2016).

Identical versions of these tests that are made by the same company but marketed under the manufacturer name apDia are sold in Belgium, Netherlands, Luxembourg, Iran and Slovenia.

A search of the Medicines and Healthcare products Regulatory Agency website revealed that no manufacturer field safety notices or medical device alerts have been issued for this technology.