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About BioSure

The Team Behind HIV Self Test

BioSure (UK) Ltd are the manufacturers of the first CE marked HIV Self Test for personal use. Since launching in 2015 BioSURE HIV Self Test, our products have helped people throughout the UK and the world, to #knowyourstatus.
We develop, manufacture and distribute world class point of care rapid tests. We also developed and launched the world's first approved HIV self test to use blood (round of applause please!)

Accredited and Clinically Recognised

BioSure(UK) Ltd is registered with the Medicines and Healthcare Agency (MHRA) and accredited with the European Medicines Agency (EMA),and UKAS.
BioSure has ISO 13485 certification. This is the internationally recognised standard for quality management system medical devices. It specifies the requirements for a quality management system that an organisation needs to demonstrate its ability to provide a medical device or service that consistently meets customer needs and regulatory requirements.

 

 
ISO 13485 | CE Mark 2797
 
 
 
 
The BioSURE HIV Self Test is a CE Marked product. This means that our products are independently tested and verified by a Notified Body. The BioSURE HIV Self Test is independently verified by the BSI Group (notified body number 2797). BioSure’s regulatory compliance is managed by Gary Carpenter, Clinical & Regulatory Affairs Officer.

 Clinically Recognised

Internationally, the BioSURE HIV Self Test has been recognised in studies by world leading HIV health organisations like PATH and WITS University.
In the UK, we have been clinically tested to give users an accurate reading when testing themselves. The test has been used for clinical studies on the impact of accessible HIV testing by the NHS, University College London, the Terrance Higgins Trust, UKCAB, Sussex University, and others.

Our Values

We understand first-hand the vital importance of ease of use and our customer's journey and considerations. Our tests provide immediate results with the highest levels of accuracy, rivalling those of standard laboratory tests.
Since launching the BioSURE HIV Self Test, we have become experts in this field and have unique and unrivalled knowledge of the global landscape. We passionately believe that self-testing can revolutionise testing protocols, reduce late diagnoses, provide economic benefits and engage hard to reach key populations.
Innovative, cost effective, simple, fast and accurate –
we bring this technology to the mainstream.
When you want to be sure........Be BioSure