Mindray Receives CE Marking Approval for HIV and HBV CLIA Test Kits
Mindray is the first and only Chinese medical device company to have passed the assessment of the European Directive 98/79/EC (IVDD) for List A tests.
SHENZHEN, China, Oct. 24, 2017 /PRNewswire/ — Mindray announced it has received CE Marking certificates issued by TUV SUD, a global certification body for medical devices, for its HIV and HBV (HBsAg, Anti-HBs, Anti-HBc, HBeAg, and Anti-HBe) CLIA (Chemiluminescence Immunoassay) test kits. Mindray becomes the first and only Chinese medical device company to receive List A CE Marking for infectious disease tests.
“Infectious disease tests are one of the most complicated and stringent CLIA assays due to complexity of samples and the existence of mutations. Over the last few years Mindray’s R&D team has been committed to tackling the difficulties and challenges. Now we have finally obtained CE certifications for these List A assays,” Mr. Haitao Huang, Vice President of Mindray Group, said at the CE certification announcement.
“We have applied a number of patented technologies in the infectious disease assays to shorten the window period and reduce the endogenous interference of samples from pregnant women, the elderly, and patients with hepatic or renal diseases,” added Mr. Zhaoyang Li, General Manager of Mindray In-Vitro Diagnostics Business Unit. Behind Mindray’s high quality products are its globally integrated innovation platform and world-class quality control system. Every year Mindray invests around 10% of its revenues in R&D to drive development of safe and dependable medical applications resulting in solutions that are trusted by customers worldwide and certified with international standards such as FDA and CE Marking.
Mindray 4th-generation HIV assay
The Mindray CL-series HIV assay is a Chemiluminescent Immunoassay for the simultaneous qualitative determination of both HIV p24 antigen prior to seroconversion, and antibodies to HIV-1 (including Group M & O) and HIV-2 in human serum or plasma. This 4th-generation HIV assay shortens the detection window and improves detection sensitivity of early HIV infection. It may be used as an aid in the diagnosis of HIV-1/HIV-2 infection and as a screening test for donated blood.
Mindray is a leading global developer of medical devices and solutions, dedicated to making better healthcare more accessible to humanity. Since its foundation in 1991, Mindray has been exclusively focused on the medical industry in the fields of Patient Monitoring & Life Support, In-Vitro Diagnostics, and Medical Imaging. www.mindray.com/en