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About BioSure

The BioSure Team Behind the OraQuick HIV Self Test

BioSure Global Ltd are proudly working with OraSure to bring you the OraQuick HIV Self Test.
The BioSure team have unique and extensive knowledge and have helped hundreds of thousands of people throughout the UK and the world, to #KnowYourStatus
We develop, manufacture and distribute world class self-tests and wellbeing products to help you take control of you. 

Accredited 

BioSure Global is registered with the Medicines and Healthcare Agency (MHRA) and has ISO 13485 certification. This is the internationally recognised standard for quality standard to manufacture medical devices. It specifies the requirements for the robust quality management system that an organisation needs to demonstrate its ability to place a medical device onto the market that consistently meets customer needs and regulatory requirements.

The OraQuick HIV Self Test is CE Marked specifically for self-testing and is proven to be easy to use and accurate when used by untrained lay-users. This means it has been independently scrutinised and verified by a Notified Body.

The OraQuick HIV Self Test is independently verified by Presafe Denmark (notified body number 0543). 

 

Clinically Recognised

The OraQuick HIV Self Test has been prequalified by the World Health Organisation (WHO) and has been used and recognised in studies by world leading HIV health organisations such as PATH and WITS University.
It holds regulatory approvals across the world and is the best-selling oral fluid HIV self-test on the planet

 

Our Values

We understand first-hand the vital importance of convenience, ease of use and our customer's journey and considerations. We are proudly distributing OraQuick HIV Self Tests to provide immediate results with the highest levels of accuracy, rivalling those of standard laboratory and blood based tests.
The BioSure team are 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 for healthcare and most importantly, it puts you in control.
Innovative, cost effective, simple, fast and accurate –
we bring this technology to the mainstream.
So when you want to be sure........Be BioSure