SELFCheck - helping improve access to a fast and reliable diagnosis
SELFCheck is a growing range of self test medical test kits from 1st Health Products Ltd which was acquired by JR Biomedical Ltd in August 2018. Our intention is to ensure UK consumers are provided with high quality, reliable, easy to use and scientifically validated lateral flow medical tests, whilst assisting retailers to ensure they provide their customers with the best possible advice.
Leaders in consumer rapid diagnostics, we are dedicated to improving human health by increasing accessibility to a fast and reliable diagnosis. That mission is behind everything we do, from commercialisation of novel biomarkers for clinical point of care testing to delivering value to our customers and investors.
Our research and manufacturing laboratories are at Glyndwr University's OpTIC Technology Centre in North Wales. As well as production of the SELFCheck range, JR Biomedical has an active R&D program developing new diagnostic technology and collaboration with Universities, including the development of a new type of lateral flow rapid test device for use by clinicians for the diagnosis of sepsis and basic research in to a laboratory based label-free homogeneous assay system.
All medical devices are developed and assembled on-site according to a strict, externally audited quality assurance system, certified to ISO13485:2016.
Each product in the SELFCheck range is CE marked for self test use according to the In Vitro Diagnostics Directive/Regulations. This certification is only granted following external independent review of the product by a Notified Body, where the manufacturer has to demonstrate that each test is of suitable sensitivity and specificity and the instructions are clear enough for lay-persons to easily use the test and interpret the results. These regulatory requirements for self test devices are over and above those necessary for equivalent tests used in NHS hospital laboratories.
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