適應症
固相化學冷光酵素免疫分析法定性檢驗/確認人體血清或血漿中之B型肝炎表面抗原(HBsAg)。  
劑型
 
包裝
L2KHB2: 200 tests, 註銷規格:L2KHB6: 600 tests, LKCH,以下空白。 
許可證字號
衛部藥製字第011185號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2025-04-08  
發證日期
2005-04-08  
許可證種類
09 
中文品名
IMMULITE 2000 B 型肝炎表面抗原檢驗/確認試劑 
英文品名
IMMULITE 2000 HBsAg/Confirmatory Kit 
藥品類別
B 血液學及病理學用裝置 
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
DHA00601118509 
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, UK GB
成份表
處方標示 成分名稱 含量 單位
1 HBsAg Bead Pack:beads coated with murine monoclonal Anti-HBs、HBsAg reagent wedges:L2HBA2:protein based buffer with preservative.......11.5ml、L2HB2:alkaline phosphate conjugated to polyclonal Anti-HBs with preservatives.......11.5ml、HBsAg adjustor:Human serum with inactivated HBsAg with preservatives.........4ml、HBsAg negative control:human serum without HBsAg........................8ml、HBsAg low positive & positive control:human serum with HBsAg, 2levels 8ml each 增列:HBsAg Confirmatory Kit Reagent 1(Blocking Reagent): One amber glass vial (1.2 mL) of polyclonal goat antibody against HBsAg in a protein-based buffer, with preservative. Reagent 2 (Control Reagent): One amber glass vial (1.2 mL) of a protein-based buffer, with preservative. Sample Diluent : Two bottles (100 mL each) of protein based buffer, with preservative. HBsAg Positive Control: One amber glass vial (8 mL) of human serum with inactivated HBsAg, with preservative.