Regulatory information

Regulatory information

The eazyplex SuperBug kits are CE marked as in vitro diagnostic devices. The company, Amplex, has current CE certification dated August 2016 which includes the following eazyplex SuperBug kits:

  • SuperBug complete A (CE marked in November 2013)

  • SuperBug complete B (CE marked in July 2014)

  • SuperBug CRE (CE marked in August 2013).

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.