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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
第 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
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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
- • 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• 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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