免疫特B 型肝炎表面抗原檢驗試劑
IMMULITE HBsAg

適應症
利用化學冷光免疫分析法定性測試人體血清或血漿中之HBsAg.  
劑型
 
包裝
LKHB1: 100 tests, LKHB5: 500 tests, LKCH。 
許可證字號
衛部藥製字第013219號 
註銷狀態
1 
註銷日期
2022-05-19  
註銷理由
888 
有效日期
2020-10-19  
發證日期
2005-10-19  
許可證種類
09 
中文品名
免疫特B 型肝炎表面抗原檢驗試劑 
英文品名
IMMULITE HBsAg 
藥品類別
B 血液學及病理學用裝置 
申請商名稱
西門子醫療設備股份有限公司  
申請商地址
臺北市南港區園區街3號2樓之2 
通關簽審文件編號
DHA00601321900 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD LL55 4EL UNITED KINGDOM GB
成份表
處方標示 成分名稱 含量 單位
1 IMMULITE HBsAgHBsAg Test Units (LHB1)Each barcode-labeled unit contains one bead coated with murine monoclonal anti-HBs.LKHB1: 100 units. LKHB5: 500 units.HBsAg Reagent Wedges (LHBA, LHBB)LHBA: 7.5 mL of a protein-based buffer, with preservative.LHBB: 7.5 mL alkaline phosphatase (bovine calf intestine) conjugated to polyclonal goat anti-HBs in buffer, with preservative. LKHB1: 1 set. LKHB5: 5 setsHBsAg Adjustor (LHBR) 4 mL of human serum with inactivated HBsAg, with preservative LKHB1: 1 vial.LKHB5: 2 vials.
1 HBsAg Controls (LHBC1, LHBC2, LHBC3)Three vials (Negative, Low Positive and Positive) containing 8 mL each. LHBC1(Negative Control): human serum without HBsAg, with preservative. LHBC2, LHBC3 (Low Positive Control, Positive Control): human serum with inactivated HBsAg, with preservative.LKHB1: 1 set. LKHB5: 2 sets.
1 IMMULITE HBsAg Confirmatory Kit HBsAg Confirmatory Assay Reagent 1 (LCH1) (Blocking Reagent): One amber glass vial (1.2 mL) of polyclonal goat antibody against HBsAg in a protein-based buffer, with <0.1 g/dL sodium azide.HBsAg Confirmatory Assay Reagent 2 (LCH2) (Control Reagent): One amber glass vial (1.2 mL) of a protein-based buffer, with <0.1 g/dL sodium azide.HBsAg Confirmatory Assay Sample Diluent (LCHZ4): Two bottles (100 mL each) of protein-based buffer, with <0.1 g/dL sodium azide. HBsAg Positive Control (LHBC3): One amber glass vial (8 mL) of human serum with inactivated ad and ay hepatitis B viral antigens, with <0.1 g/dL sodium azide.