"必帝" 砂眼披衣菌/淋病雙球菌分子生物鑑定試劑組

"BD" ProbeTec ET CT/GC Amplified DNA Assays

衛署醫器輸字第012283號

本站收錄狀態已註銷

有效日期2010 / 09 / 09

醫療器材級數未載明

這張許可證已註銷（2012/10/26，許可證已逾有效期），以下僅供查閱歷史資料。申請商為 美商必帝股份有限公司台灣分公司。以下整理許可證、規格與製造廠資料，供核對產品身分使用。

許可證資料依公開資料欄位整理

效能: 利用DNA放大原理，快速鑑定臨床檢體種類之儀器系統。
規格: CT/GC Control Set (#440451): 20 positive and 20 negativeCT/GC Reagent Pack (#440705): 384 testsCT/GC/AC Reagent Pack (#440450): 384 tests
主成分: Each BDProbeTec ET CT/GC Reagent Pack contains:Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Priming Microwells, 4×96:4 Oligonucleotides ≧7 pmol; dNTP ≧35 nmol; Detector probe ≧25 pmol; with buffers and stabilizers.Chlamydia trachomatis (CT) Amplification Microwells, 4×96:Restriction enzyme ≧30 Units; DNA Polymerase ≧25 Units; dNTP’s ≧80 nmol; with buffers and stabilizers.Neisseria gonorrhoeae (GC) Amplifaication Microwells, 4×96:Restriction enzyme ≧15 Units; DNA Polymerase ≧2 Units; dNTP’s ≧80 nmol; with buffers and stabilizers.The BDProbeTec ET CT/GC/AC Reagent Pack contains:Amplification Control (AC) Priming Microwells, 4×96:4 Oligonucleotides ≧7 pmol; dNTP ≧35 nmol; Detector probe ≧25 pmol; approximately 1,000 copies per reaction of pGC10 linearized plasmid; with buffers and stabilizers.Amplification Control (AC) Amplification Microwells, 4×96:Restriction enzyme ≧15 Units; DNA Polymerase ≧2 Units; dNTP’s ≧80 nmol; with buffers and stabilizers.

可改用包裝上的完整型號或許可證字號查詢。