On September 28th, 2023, Mindray Anti-HCV assay was granted the Class D certificate under the In Vitro Diagnostics Regulation (IVDR) by TÜV SÜD.
Mindray has achieved a significant milestone as the first Chinese company to obtain CE IVDR Class D certification for Anti-HCV assay in the field of CLIA.
Anti-HCV Assay IVDR Class D Certificate
The latest IVDR divides in vitro diagnostic (IVD) devices into four classes according to their potential risk during use: A, B, C, and D.
Class D devices are classified as having the highest level of risk. These devices are required to gothrough rigorous clinical trials in Europe, along with complex conformity assessment procedures.
Mindray has established itself as a pioneering presence in the field of IVD in China. The company's acquisition of the IVDR Class D certificate is not only indicative of its meticulous compliance with regulatory standards across different countries and regions, but also its unwavering commitment to maintaining exceptional product quality through strict adherence to rigorous processes for clinical trials and data management.
Mindray Anti-HCV assay employs specially designed recombinant protein sequences as capture antigens, enhancing the binding affinity of specific antibodies and effectively mitigating the risk of interference. It enables the simultaneous detection of both IgG and IgM antibodies, facilitating the early identification of individuals undergoing HCV seroconversion. Mindray Anti-HCV assay, with high specificity and sensitivity is a valuable tool for supporting the diagnosis of hepatitis C virus infections, as well as the screening of samples from blood donation and the testing of blood components.
Mindray has successfully secured IVDD CE List A certification for its HIV and hepatitis B virus assays. With the recent acquisition of IVDR Class D certification for its Anti-HCV assay, Mindray is now equipped to offer a full menu of infectious disease tests with proven quality.
