diabetes mellitus | 合法醫療器材資訊網
FDA recently granted premarket notification (510(k)) clearance to Ortho-Clinical Diagnostics, Raritan, NJ, for its Vitros Chemistry Products HbA1c reagent kit, to be used on the Vitros 5600 integrated system, Vitros 4600 chemistry system, and Vitros 5,1 FS chemistry system.
The test can be used for the quantitative determination of percent glycated hemoglobin A1c and mmol/mol hemoglobin A1c in human whole blood. The test is to be used as an aid in the diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for monitoring long-term blood glucose control in individuals with diabetes mellitus.
The newly cleared HbA1c kit offers operational and performance enhancements over the company’s currently marketed kit, including higher throughput and simplified calibration. The design of the Vitros HbA1c assay allows its use in patients with...
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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/...