VANC2 and Vancomycin (ONLINE TDM VANCOMYCIN FOR ... | 合法醫療器材資訊網
A reference standardization of the Roche vancomycin assays was done by the manufacturer against the reference method. It was decided to correct both methods against the reference method. The COBAS INTEGRA assay was corrected by a reagent modification. The instruction for use of the vancomycin assays already show a method comparison against COBAS INTEGRA with the changed formulation which is not yet available on the market. This may lead to the assumption that both methods are comparable and may affect the interpretation of results. Since the COBAS INTEGRA reagent is not yet adapted, results generated with COBAS INTEGRA are still up to 20% higher than with cobas c or modular p systems.
Affected products A. VANC2 (ONLINE TDM VANCOMYCIN FOR ROCH...羅氏可霸斯萬古黴素檢驗試劑 | 合法醫療器材資訊網
羅氏可霸斯萬古黴素檢驗試劑 | 合法醫療器材資訊網
International Medical Devices Database | 合法醫療器材資訊網
vanc2 (online tdm vancomycin for rochehitachi cobas c 311 and c ... | 合法醫療器材資訊網
Class 2 Device Recall Roche VANC2 | 合法醫療器材資訊網
VANC2 and Vancomycin (ONLINE TDM VANCOMYCIN FOR ... | 合法醫療器材資訊網
醫療器材仿單或外盒資料集 | 合法醫療器材資訊網
醫療器材許可證資料集 | 合法醫療器材資訊網
【羅氏可霸斯萬古黴素檢驗試劑】許可證字號:衛署醫器輸字第025080號
器材品名:羅氏可霸斯萬古黴素檢驗試劑許可證字號:衛署醫器輸字第025080號註銷狀態:註銷日期:註銷理由:有效日期:2018/07/02發...