Rapid Antigen Test
All medical devises have to follow a standard process before they can be sold in the EU. These tests have been through that process and have a CE mark. They can be sold and used in the UK & Ireland within their intended use.
The MHRA is the competent authority or regulatory body in the UK. They do not approve tests other than to allow the manufacturers to put a CE mark on the product. The MHRA did, however, produce a target product proĮle that contains criteria that tests should meet. The antigen tests meet all of the target profile.
Public Health England have been assessing tests in the UK at their labs in Porton Down. Although Flownex has been submitted for review, it has not yet been called up for evalution. As and when this happens we will advise our customers.