UKCA / IVD mark achieved for Immuno-T At Home Blood Collection Kit

The kit is now registered with the UK’s MHRA (Medicines & Healthcare products Regulatory Agency) as an In Vitro Diagnostic (IVD) Medical Device (MD). The registration of the kit with the UK’s MHRA will ensure the quality assurance of this product and provide confidence to any customers wishing to use the device. The registration and documentation was made possible with the support of Charlotte James of James QA and funding from InnovateUK and CPI.

Dr James Hindley, CEO of ImmunoServ said “Registration of our At Home Blood Collection Kit represents another huge step forward for ImmunoServ and our ongoing commitment to bringing T cell testing to the masses. We would like to thank all the volunteers who helped in the validation of the kit.”

Dr Martin Scurr, CSO of ImmunoServ added “The validation study of the kit has been a great success, we are looking to get the kit on the market within the next few weeks so that it can be purchased by the public for monitoring their immunity to COVID. We have also now submitted our validation study for peer review and hope to have this published very soon”.