適應症
羅氏安可披衣菌/淋菌檢驗套組係利用分子診斷方法,於體外進行定性測試,藉著偵測泌尿生殖道檢體之披衣菌/淋菌核酸的有無,篩檢是否感染披衣菌及淋菌。  
劑型
 
包裝
AMPLICOR CT/NG Specimen Preparation Kit: 100 Tests、AMPLICOR CT/NG Amplification Kit: 96 Tests、COBAS AMPLICOR Chlamydia trachomatis Detection Kit: 100 Tests、COBAS AMPLICOR Nesseria gonorrhoeae Detection Kit: 100 Tests、COBAS AMPLICOR Detection Reagent Kit: 100 Tests、COBAS AMPLICOR Wash Buffer 500 tests 
許可證字號
衛部藥製字第013117號 
註銷狀態
註銷日期
2018-05-28  
註銷理由
838 
有效日期
2015-09-30  
發證日期
2005-09-30  
許可證種類
09 
中文品名
羅氏安可披衣菌/淋菌核酸檢驗套組 
英文品名
COBAS AMPLICOR CT/NG Test 
藥品類別
C 免疫學及微生物學用裝置 
申請商地址
台北市中山區民權東路3段2號10樓 
通關簽審文件編號
DHA00601311702 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ROCHE MOLECULAR SYSTEM, INC. 1080 US HIGHWAY 202 SOUTH BRANCHBURG, NJ 08876, USA US
成份表
處方標示 成分名稱 含量 單位
1 Amplicor CT/NG Speciment Preparation Kit 100 Tests CT/NG URINE WASH (CT/NG Urine Wash Buffer)1×50 mL, CT/NG LYS (CT/NG Lysis Reagent) 1×25 mL, CT/NG DIL (CT/NG Specimen Diluent) 2×50 mL, Amplicor CT/NG Amplification Kit 96 Tests CT/NG MMX (CT/NG Master Mix) 3×1.8 mL, CT/NG IC (CT/NG Internal Control) 3×0.1 mL, CT(+)C [C. trachomatis (+) Control] 1×0.8 mL, NG(+)C [C. trachomatis (-) Control] 1×0.8 mL, COBAS AMPLICOR Chlamydia trachomatis Detection Kit 100 Tests
1 CT PS1 (CT Probe Suspension 1) 1×100 Tests, CT 4 (CT Probe Suspension 2) 1×100 Tests, COBAS AMPLICOR Nesseria gonorrhoeae Detection Kit 100 Tests NG PS1 (NG Probe Suspension 1) 1×100 Tests, NG4 (NG Probe Suspension 2) 1×100 Tests, COBAS AMPLICOR Detection Reagent Kit 100 Tests DN4 (Denaturation Solution) 1×100 Tests, CN4 (Avidin-Horseradish Peroxiase Conjugate) 1×100 Tests, SB3 (Substrate A) 5×75 Tests, SB (Substrate B) 5×5 mL COBAS AMPLICOR Wash Buffer WB (10X-Wash concentrate) 2×250 Tests