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Information for members of the public, patients, professionals and industry about COVID-19 tests and testing kits, including how they work, the different types of tests and the specifications manufacturers need to follow.
In the 'For industry and manufacturers' section: added new content on performance evaluation process for test kits, re-worded the description of the TTP and re-worded the list of information to send for a device exemption application.
Updated 'For patients, the public and professional users' and 'For industry and manufacturers' with new information on temporarily stopping the sale of COVID-19 antibody tests for members of the public until the regulatory and safety concerns are resolved.
Added new HTML document on the process for developing and evaluating novel molecular assays for COVID-19