[F1Register of approved coronavirus test devicesU.K.
38C.—(1) The Secretary of State must establish a register of coronavirus test devices which the Secretary of State has approved in accordance with regulation 38A.
(2) The Secretary of State must publish the register on the gov.uk website.
(3) The register must contain the following information in respect of each coronavirus test device—
(a)the name and address of the registered place of business of the person who made the application under regulation 38A;
(b)if the person who made the application was not the manufacturer, the name and address of the registered place of business of the manufacturer;
(c)the country in which the manufacturer is established;
(d)the name and address of the registered place of business of the UK responsible person or the manufacturer’s authorised representative having a registered place of business in Northern Ireland, if there is one in respect of the device;
(e)the name and description of the coronavirus test device;
(f)the date and version number of the instructions for use included in the application;
(g)whether the coronavirus test device is an antigen test, a direct molecular test, or an extracted molecular test;
(h)the date on which the coronavirus test device was approved in accordance with regulation 38A and the date on which that approval ceases to be valid.
(4) The register may contain such other information relating to the coronavirus test device and its intended use as the Secretary of State considers appropriate.]
Textual Amendments