"必帝" 自動螢光分子生物鑑定系統
"BD" ProbeTec ET System

適應症
本系統乃利用DNA放大原理(Strand Displacement Amplification (SDA)定性檢測砂眼披衣菌和淋病雙球菌。  
劑型
 
包裝
#440452, #440453, #440454, #440474, #440478, #440704, #440716 註銷規格：440454，以下空白。 
許可證字號
衛部藥製字第015753號 
註銷狀態
1 
註銷日期
2022-06-07  
註銷理由
838 
有效日期
2020-12-26  
發證日期
2005-12-26  
許可證種類
09 
中文品名
"必帝" 自動螢光分子生物鑑定系統 
英文品名
"BD" ProbeTec ET System 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
新加坡商必帝股份有限公司台灣分公司  
申請商地址
台北市信義區忠孝東路四段560號3樓 
通關簽審文件編號
DHA00601575301 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
BECTON, DICKINSON AND COMPANY (BD) 7 LOVETON CIRCLE SPARKS, MD 21152, USA US
成份表
處方標示 成分名稱 含量 單位
1 Each BDProbeTec ET CT/GC Reagent Pack contains:\nChlamydia trachomatis (CT) Priming Microwells, 4x96:\n4 Oligonucleotides ≧7 pmol; dNTP ≧35 nmol; Detector probe ≧25 pmol;\nNeisseria gonorrhoeae (GC) Priming Microwells, 4x96:\n4 Oligonucleotides ≧7 pmol; dNTP ≧35 nmol; Detector probe ≧25 pmol;\nChlamydia trachomatis (CT) Amplification Microwells, 4x96:\nRestriction enzyme ≧30 Units; DNA Polymerase ≧25 Units; dNTP’s ≧80 nmol;\nNeisseria gonorrhoeae (GC) Amplification Microwells, 4x96:\nRestriction enzyme ≧15 Units; DNA Polymerase ≧2 Units; dNTP’s ≧80 nmol;\nAmplification Control (AC) Priming Microwells, 4x96:\n4 Oligonucleotides ≧7 pmol; dNTP ≧35 nmol; Detector probe ≧25 pmol; approximately 1,000 copies per reaction of pGC10 linearized plaasmid;
1 Amplification Control (AC) Amplification Microwells, 4x96:\nRestriction enzyme ≧15 Units; DNA Polymerase ≧2 Units; dNTP’s ≧80 nmol;\nBDProbeTec ET (CT/GC) Control Set, 20 CT/GC Positive Controls (50 μL dried) containg 750 copies per reaction of pCT16 linearized plasmid* and 250 copies per reaction of pGC10 linearized plasmid* with ≧5 μg Salmon tests DNA;\n20 CT/GC Negative Controls (50 μL dried) with ≧5 μg Salmon tests DNA; BDProbeTec ET CT/GC Diluent Tubes-400 tubes each containing 2 mL of Sample Diluent, which contains potassium phosphate, DMSO, glycerol, Polysorbate 20, and 0.3% Proclin; BDProbeTec ET Diluent (CT/GC)-225 mL Sample Diluent which contains potassium phosphate, DMSO, glycerol, Polysorbate 20,and 0.03% Proclin.\n
1 Instrument, equipment and supplies: BDProbeTec ET Instrument and Instrument Plates, BDProbeTec ET Lysing Heater, Lysing Rack and base, BDProbeTec ET Priming and Warming Heater, BDProbeTec ET Pipettor and Power Supply, BDProbeTec ET Urine Processing Kit (containing Urine Processing Pouches/UPPs), BDProbeTec ET Sample Tubes, Caps, and Pipette Tips, BDProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit or BDProbeTec ET Chlamydia trachomatis/Nesseria gonorrhoeae (CT/GC) Amplified DNA Assay Collection Kit for Endocervical Specimens, BDProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Male Urethral Specimen Collection and DRY TRANSPORT Kit or BDProbeTec ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collection Kit for Male urethral Specimens.