適應症
放射性免疲法測定IGM-ANTI-HBC 
劑型
 
包裝
 
許可證字號
衛署醫器製字第R01237號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2024-11-06  
發證日期
2005-01-10  
許可證種類
09 
中文品名
普生克肝碘125MB 
英文品名
ANTICORDINE 125 MB 
藥品類別
B 血液學及病理學裝置 
申請商名稱
普生股份有限公司  
申請商地址
新竹縣寶山鄉新竹科學園區創新一路6號 
通關簽審文件編號
DHY005R0123701 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
普生股份有限公司 新竹縣寶山鄉新竹科學園區創新一路6號 TW
成份表
處方標示 成分名稱 含量 單位
1 每套組含:1.Anti-IgM beads: Five trays each with 20 beads coated with purified antibodyto human IgM are packed in plastic bag with desiccant.2.125I‧Anti-HBc Solution: Ten bottles, 1ml each( or 2 bottles, 5ml each) 125I labeled Anti-HBc (Human) dissolved in protein stabilizer. The maximum radioactivity was 5.5μCi/ml on iodination day. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin. 3.IgM anti-HBc Positive Control: One bottle (3.0ml) human serum, containing diluted IgM anti-HBc. It should be used directly and need not to be diluted again. Minimum titer:1:2 Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.4.HB IgM anti-HBc Negative Control: One bottle (4ml) diluted normal human serum contains protein stabilizer. It should be used directly and need not to be diluted again. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.5.Hepatitis B core antigen(HBcAg) Reagent: One bottle (10ml) of human HbcAg in saline and protein stabilizer, Minimum titer 1:64. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.6.Specimen diluent: one bottle (60ml), contains phosphate Buffered saline and protein stabilizer. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.