適應症
ARCHITECT SHBG是一化學冷光微粒酵素免疫分析法(CMIA),可定量測試人體血清或血漿中之性荷爾蒙結合球蛋白(SHBG)。  
劑型
 
包裝
8K26-20:100 tests,8K26-25:400 tests8K26-018K26-10 
許可證字號
衛部藥製字第018288號 
註銷狀態
註銷日期
2024-04-12  
註銷理由
838 
有效日期
2022-06-23  
發證日期
2007-06-23  
許可證種類
09 
中文品名
亞培設計師性荷爾蒙結合球蛋白檢驗試劑組 
英文品名
ABBOTT ARCHITECT SHBG 
藥品類別
A 臨床化學及臨床毒理學 
申請商地址
臺北市中山區民生東路3段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00601828802 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BIOKIT S.A. CAN MALE S/N 08186 LLICA D'AMUNT, BARCELONA, SPAIN ES {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}, {"value":"P01","name":"Manufactured by"}
ABBOTT GMBH & CO. KG MAX-PLANCK-RING 2, 65205 WIESBADEN GERMANY DE {"value":"P02","name":"\u59d4\u8a17\u88fd\u9020\u8005"}
成份表
處方標示 成分名稱 含量 單位
1 ARCHITECT SHBG Calibrators\n6 Bottles (2.0 mL each) of ARCHITECT SHBG Calibrators. Calibrator A contains phosphate buffered saline with protein stabilizer. Calibrators B to F contain SHBG\nARCHITECT SHBG Controls\n3×1 Bottle(4.0 mL each)of ARCHITECT SHBG Controls contain SHBG\nARCHITECT Reagent Kit, 100/400 Tests\nMicroparticles:1 or 4 Bottle(s)(6.6 mL each)Anti-SHBG coated microparticles in TRIS buffer. Preservative:sodium azide.\nConjugate:1 or 4 Bottle(s)(5.9 mL each)Anti-SHBG acridinium-labeled conjugate in phosphate buffer with protein(mouse, bovine)stabilizers. Preservative:sodium azide.\nAssay Diluent:1 or 4 Bottle(s)(8.0 mL each)SHBG Assay Diluent containing phosphate buffer with protein (mouse, bovine)stabilizers. Preservative:sodium azide.\n