SELFCHECK® Information for Health Care Professionals
Science for a healthier life
Quality assurance
All SELFCHECK® health screening tests are assembled at our UK facility according to a full quality assurance system. This quality system is independently audited annually by UKAS certified auditors, with additional quality assurance meetings held quarterly, to review R&D, manufacturing processes, and feedback from customers. This information is documented, analysed and used for product and service improvement.
Pre and post-test help and advice
The instruction leaflet accompanying each health screening test provides clear guidance on its intended use and the steps for a user to take following a positive or negative result. This information has been reviewed by the Notified Body responsible for UK and EU product certification under IVDD/IVDR legislation.
Whilst we cannot provide medical advice on the basis of a single test result, support is available for users who require further help, from our R&D staff who have a clinical, health, or science background, to assist users with using the test or interpreting their result. Contact details are provided within the instruction leaflet.
Analytical performance and regulatory information
Data sheets for SELFCHECK health screening tests are provided below. All SELFCHECK medical products are;
- CE certified specifically for self testing according to IVDD/IVDR
- registered with MHRA
- assembled in the UK at an ISO 13485:2016 certified facility
- validated with laboratory diagnostics and international standards where appropriate
All information has been provided by the manufacturers and will be updated when further details are available.
Please contact us directly for specific technical or regulatory information.
Updated 15th August 2025
Faecal Immunochemical Test (FIT)
Gluten Sensitivity (Coeliac Disease)
Stomach Ulcer Test (Helicobacter pylori)