MAUDE Adverse Event Report | 合法醫療器材資訊網
ADVIACENTAURXPCEAASSAYCEAIMMUNOASSAY...manufacturerscanvaryduetodifferencesinassaymethods,calibration,andreagentspecificity.
Siemens healthcare diagnostics is investigating the cause of the discordant advia centaur xp cea results.The instruction for use (ifu) limitation section states: "warning do not use the advia centaur cea immunoassay as a screening test for diagnosis.Note do not interpret levels of cea as absolute evidence of the presence or the absence of malignant disease.Measurements of cea should always be used in conjunction with other diagnostic procedures, including information from the patients clinical evaluation.The concentration of cea in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Cea determined with different manufacturers assays will vary depending on the method of standardization and antibody sp...
April 13 | 合法醫療器材資訊網
Validation of Assaying Carcinoembryonic Antigen in Human ... | 合法醫療器材資訊網
Comparison of Four Automated Carcinoembryonic Antigen ... | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
k071603 B. Purpose for Submission | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
"西門子"癌胚抗原試劑組"SIEMENS" Reagents for CEA Assay} | 合法醫療器材資訊網
Siemens 10311624 | 合法醫療器材資訊網
【"西門子"癌胚抗原試劑組】許可證字號:衛署醫器輸字第015105號
器材品名:"西門子"癌胚抗原試劑組許可證字號:衛署醫器輸字第015105號註銷狀態:註銷日期:註銷理由:有效日期:2025/11/29發證日...