Ortho | 合法醫療器材資訊網
US-based Ortho-Clinical Diagnostics has received CE Mark for the Vitros chemistry products HbA1c reagent kit, an enhanced assay to detect and monitor blood glucose levels over time in diabetes patients.
The assay helps to find the percentage of glycated haemoglobin (HbA1c) in human whole blood, and is also designed as an aid in the diagnosis of diabetes. It can also help to identify patients who may be at risk of developing diabetes.
The company intends to launch the product in the European Economic Area and several other countries in November this year.
Using Vitros MicroTip technology, the new assay runs on the company’s Vitros chemistry and integrated systems and offers operational, performance and clinical improvements compared to the existing assay.
"The company intends to launch the product in the European Economic Area and se...
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【維特司生化產品醣化血色素試劑組】許可證字號:衛部醫器輸字第032425號
器材品名:維特司生化產品醣化血色素試劑組許可證字號:衛部醫器輸字第032425號註銷狀態:註銷日期:註銷理由:有效日期:2024/05/...