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“西門子” A型肝炎免疫球蛋白M抗體檢驗試劑組

🩺 醫材

ADVIA Centaur HAV IgM

衛署醫器輸字第021670號

醫材分類

3 等級
  • B.4020分析特定試劑

醫器規格

#05004126, #05004800

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適應症

定性偵測人體血清或血漿中是否有A型肝炎病毒免疫球蛋白M抗體。

醫材資訊

主成分
.HAV IgM ReadyPack includes :\n(1) Lite Reagent 5.0 ml containing Monoclonal antibody (F(ab)2 fragment; ~0.3 μg/ml) labeled with acridinium ester in buffer with bovine serum albumin, surfactant, sodium azide (<0.1%) and preservatives.\n(2) Solid phase 15.0 ml containing streptavidin coated paramagnetic microparticles in buffer with bovine serum albumin, surfactant, sodium azide (<0.1%) and preservatives.\n(3) Antigen well reagent 5.0 ml containing inactivated hepatitis A virus (<0.1 μg/ml) in buffer with bovine serum albumin, surfactant, sodium azide (<0.1%), and preservatives. \n(4) Ancillary Reagent 25.0 ml containing biotinylated monoclonal mouse anti-human IgM (~0.500 μg/ml) in buffer with bovine serum albumin, mouse IgG, surfactant, sodium azide (<0.1%), and preservatives. \n(5) HAV IgM calibrator vials: 2.0 ml/vial processed human plasma positive for IgM antibodies to HAV with preservatives.\n.HAV IgM quality control material 7.0 ml/via containing l processed human plasma negative and positive for \nIg
製造商
SIEMENS HEALTHCARE DIAGNOSTICS INC.
製造國
US
申請商
西門子醫療設備股份有限公司
有效日期
2030/10/29
發證日期
2010/10/29

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