Ortho Clinical Diagnostics announces FDA approval of ... | 合法醫療器材資訊網
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Operational, performance and clinical improvements without having results interfered by common hemoglobin variants demonstrate company commitment to meet evolving customer needs
Ortho Clinical Diagnostics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the VITROS® Chemistry Products HbA1c Reagent[1] Kit to be used on the VITROS® 5600 Integrated System, VITROS® 4600 Chemistry System, and the VITROS® 5,1 FS Chemistry System. The test can be used for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) 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 the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
“The VITROS® Chemistry Pro...
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Ortho Clinical Diagnostics Announces FDA ... | 合法醫療器材資訊網
Ortho Clinical Diagnostics announces FDA approval of ... | 合法醫療器材資訊網
ORTHO CLINICAL DIAGNOSTICS BRADLEY BOYER ... | 合法醫療器材資訊網
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VITROS Chemistry Products d A1c Reagent Kit HbA1c ... | 合法醫療器材資訊網
![](https://i.imgur.com/6y29Lx7.jpg)
【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/...