Mindray Receives CE Marking Approval for HIV and HBV CLIA Test Kits

Food and Healthcare Press Releases Wednesday October 25, 2017 08:04
SHENZHEN, China--25 Oct--PRNewswire/InfoQuest
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.

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:

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


Latest Press Release

INSIGHTEC#s Focused Ultrasound Earns Positive NICE Guidance for Treatment of Essential Tremor

Unilateral MRI-guided Focused Ultrasound Thalamotomy for Treatment-resistant Essential Tremor Recognised by National Institute for Health and Care Excellence INSIGHTEC(R) , a global medical technology innovator of incisionless surgery, announced today...

Venus Medtech Enters North American Market

- First Clinical Implantation of Transcatheter Pulmonary Valve VenusP-Valve in North America was Successfully Performed in Vancouver, Canada On June 12, 2018, St Paul 's Hospital in Vancouver, Canada successfully completed two cases of VenusP-Valve...

What You Think About Getting Old Impacts Your Health, Quality of Life According to New Orb Media Reporting

New Orb Media Inc. reporting and data analysis [ https://www.orbmedia.org/agewell ] shows a strong connection between how we view old age, how well we age and the effects seen across world cultures. Individuals with a positive attitude towards old age...

Johnson Johnson Announces Acceptance of Binding Offer From Platinum Equity To Acquire LifeScan, Inc.

Johnson & Johnson (NYSE: JNJ) today announced that it has accepted the binding offer from Platinum Equity, previously announced on March 16, 2018, to acquire its LifeScan business for approximately $2.1 billion. LifeScan, Inc. is a world leader in...

KTC in association with Bangkok Hospital give a talk on Minimally Invasive Surgery and offer a package of Ovarian and Uterine Cancer Screening.

"KTC" or Krungthai Card Public Company Limited by Ms. Sireerat Corvanich, Vice President - Credit Card Business, sees the importance of health care for women especially with pelvic examination, therefore in association with Women Health Center of Bangkok...

Related Topics