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“西門子” A型肝炎抗體檢驗試劑組

🩺 醫材

ADVIA Centaur HAV Total

衛署醫器輸字第021406號

醫材分類

3 等級
  • B.4020分析特定試劑

醫器規格

ADVIA Centaur HAV Toatl主要試劑組ADVIA Centaur HAV Quality Control Material品管物

限制項目

輸 入

適應症

定量偵測人體血清與血漿中之A型肝炎病毒抗體。

醫材資訊

主成分
&#8226; HAV Total ReadyPack includes :\n(1) Lite Reagent 10.0 ml containing Monoclonal mouse anti-HAV (~0.1 μg/ml) labeled with acridinium ester and biotinylated monoclonal anti-HAV Fab fragment (~0.08 μg/ml) in phosphate buffer with bovine serum albumin, sodium azide (<0.1%) and preservatives.\n(2) Solid phase 17.5 ml containing streptavidin coupled to paramagnetic particles in phosphate buffer with bovine serum albumin, sodium azide (<0.1%) and preservatives.\n(3) Antigen reagent 10.0 ml containingHAV antigen (~0.06 μg/ml) in tricine buffer with bovine serum albumin, stabilizers, sodium azide (<0.1%), and surfactant. \n(4) Ancillary Reagent 25.0 ml containing cysteine in citrate buffer with EDTA and preservatives. \n(5) HAV Total calibrator vials: 2.0 ml/vial processed human plasma positive for anti-HAV antibodies with sodium azide (<0.1%).\n&#8226; HAV Total quality control material containing 7.0 ml/vial processed human plasma negative and positive for Anti-HAV antibodies with sodium azide (<0.1%).\n
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
2030/08/24
發證日期
2010/08/24

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