CE-marked assays

CE-marked assays are tests or diagnostic tools that meet European safety, health, and environmental protection standards. The CE marking indicates that the manufacturer has demonstrated the product's compliance with relevant regulations, ensuring it is safe and effective for use. This marking allows the product to be sold in the European Economic Area (EEA) and assures users, including healthcare professionals and patients, that it meets specific European requirements. Essentially, a CE mark signifies that the assay has passed rigorous evaluations and is reliable for its intended purpose.