About SELFCHECK
We're making self-testing better
At SELFCHECK, we only use high quality, hospital grade components from certified medical device manufacturers. Our quality assurance system means that we have full traceability of all components used in our tests, each of which has been tested according to international standards. The test kits are assembled at our ISO13485 certified medical device facility in the UK.
Collaborating with universities, scientists and clinicians, our innovation team develops new medical diagnostics to help diagnose and monitor health conditions.
Our extensive range of research diagnostics provide scientists with the tools they need to make their work easier and faster.
SELFCHECK self-test kits can be found in many major UK retailers, as well as independent pharmacies and online.
Our aim with SELFCHECK is to provide easy access to high quality self-test kits that are based on the same clinically proven principles found in hospital laboratory tests used by doctors, along with professional customer care.
Medical tests, whether used at home or in the hospital lab, are regulated in the UK and EU in exactly the same way, ensuring that our tests are safe, easy to use, and give reliable results. All SELFCHECK medical tests are certified for self test use according to current UK legislation, the In Vitro Diagnostics Directive/Regulations (IVDD/R) and registered with MHRA.
In the UK, the current regulations for self-test devices are far stricter than the requirements for hospital tests. Certification is only granted following an external review of each test by an independent Notified Body, where the manufacturer has to demonstrate that each test;
- conforms to accepted analytical and clinical performance
- only contains components, such as the device, lancets and swabs, that are the same high quality as those used in clinics and hospital labs
- has instructions that are clear enough for lay-persons to easily use the test and interpret their results
- contains advice on what to do with results once you have completed the test
- contains information on how to contact the manufacturer for help
- encourages you to speak with your doctor regarding your health concerns
Self test kits aren't meant to replace traditional healthcare pathways but whether a positive or negative result, self tests can help provide a prompt to seek help from the pharmacist or doctor.
SELFCHECK® is a registered trademark.
J R Biomedical Ltd is ISO 13485:2016 certified for the design, development, assembly, and distribution of medical diagnostics. Full member of the The British In Vitro Diagnostics Association (BIVDA).
