岱安韶韻黃體生成激素分析試劑
DiaSorin LH-CTK-4

適應症
體外檢驗人類血清及血漿中的黃體生成激素之免疫放射量。  
劑型
 
包裝
#P001908: 100 tubes/kit 
許可證字號
衛部藥製字第016598號 
註銷狀態
1 
註銷日期
2012-10-26  
註銷理由
838 
有效日期
2011-05-18  
發證日期
2006-05-18  
許可證種類
09 
中文品名
岱安韶韻黃體生成激素分析試劑 
英文品名
DiaSorin LH-CTK-4 
藥品類別
A 臨床化學及臨床毒理學 
申請商名稱
新科化實業有限公司  
申請商地址
臺北市中正區忠孝西路１段５０號１４樓之４ 
通關簽審文件編號
DHAS0601659802 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN S.P.A. VIA CRESCENTINO SNC, 13040 SALUGGIA (VC), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 Anti-LH antibody-coated tubes: 2 x 50 tubes (ready-to-use)125I-labeied monoclonal anti-LH antibody: one 5.5 mL vial (ready-to use)The vial contains 370 kBq, at the date of manufacture, of 125Ilabeled immunoglobulins in buffer with bovine serum albumin, sodium azide (<0.1%; see § Precautions), and a dye.Standards: six vials (lyophilized)The standard vials contain from 0 to 180 IU/L of LH in horse serum with sodium azide (<0.1%, see § Precautions). The exact concentration is indicated on each vial. The standards were calibrated against the international standard WHO 2nd IS 80/552.Control sera: one vial (lyophilized)The vial contains human LH lyophilized in human serum (see § Precautions). The expected values are in the concentration range indicated on a supplement. Wash solution (20x): one 50 mL vialConcentrated solution has to be diluted before