Vstrip ® H. pylori Antigen Rapid Test | 合法醫療器材資訊網
INTEND USE Vstrip H. pylori Antigen Rapid Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
FEATURES
Method: Monoclonal immunochromatographic assay Specimen: Stool Detection device: Cassette Time to Result: 10 minutes External Quality Control: Positive control reagent Package: 20 tests/kit Storage temperature: 15-30℃
PERFORMANCE CHARACTERISTICS The evaluation was conducted comparing the results obtained using Vstrip H. pylori Antigen Rapid Test to an FDA-cleared ELISA that was previously evaluated relative to the endoscopy biopsy composite reference ...
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【創安幽門螺旋桿菌快速檢驗試劑(未滅菌)】許可證字號:衛部醫器輸壹字第020845號
器材品名:創安幽門螺旋桿菌快速檢驗試劑(未滅菌)許可證字號:衛部醫器輸壹字第020845號註銷狀態:註銷日期:註銷理由:有效日期:...