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Automatic Coagulation Analyzers Receive CE IVDR Certification

Source:Autobio DiagnosticsTime:2024.09.03

Please be advised that on 26 May 2022, the European Union fully implemented the new regulation EU 2017/746 (IVDR) for in vitro diagnostics. The new regulation introduces more rigorous standards for all aspects of technical documentation review, clinical evaluation, and post-market surveillance. It also necessitates enhanced product quality and device traceability throughout the supply chain, up to the end user.

 
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Thrombosis and haemostasis testing is a crucial tool for diagnosing and supporting the diagnosis of related diseases. However, due to the inherent variability between tests, the efficiency of comprehensive testing of coagulation items has consistently been a challenge in this field.

 
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In 2017, Hicken Medical launched the fully automatic coagulation analyzer Ci-310, the first of its kind in China to achieve a constant speed of 300 tests/hour for coagulation testing. It was also the first to achieve a coagulation method with 4-wavelength co-testing, which allows for more accurate detection of abnormal specimens. The all-liquid and concentrated supplies are more convenient to use, making it an ideal solution for medium-sized and large-sized laboratories seeking to improve coagulation testing efficiency and address quality issues with abnormal samples. This solution is the preferred choice for medium and large laboratories seeking to address challenges related to coagulation testing efficiency and abnormal sample quality.

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The fully automatic coagulation analyzer Ci-120x has been designed with the needs of small and medium-sized testing laboratories in mind. It offers a maximum testing speed of 300 tests per hour and the ability to simultaneously test four or seven coagulation tests, with a combined mixing speed of up to 120 tests per hour.

 

Autobio will continue to expand its range of coagulation products, enhance their performance and quality, and provide a broader selection of products and services to both domestic and international customers.