亞培砂眼披衣菌/淋病雙球菌檢驗試劑套組

醫材分類

• C.3120披衣菌血清試劑

醫器規格

9K12-01/9K12-03, 8L07-80/2G28-80, 8L07-90/2G28-91 申請變更項目：變更規格(新增檢體處理適用機型)及仿單：詳如中文仿單核定本(原98.5.27核准之仿單、標籤核定本予以回收作廢)。 規格、標籤、說明書或包裝變更為：詳如核定之中文說明書。（原113年3月1日核定之標籤、說明書或包裝予以回收作廢）

限制項目

輸 入

適應症

效能變更：本產品為體外聚合酶連鎖反應(PCR)分析，用來直接定性偵測女性子宮內頸或陰道拭子檢體、男性尿道拭子檢體或男性及女性尿液檢體中的砂眼披衣菌(C trachomatis)質體DNA及淋病雙球菌(N gonorrhoeae)基因體DNA。

醫材資訊

主成分

8L07-80/2G28-80 Abbott RealTime CT/NG Control Kit\n1.Abbott RealTime CT/NG Negative Control\nBuffered solution with carrier DNA. Preservatives：Sodium azide and 0.15% ProClin 950. 2.Abbott RealTime CT/NG Cutoff\n<0.01% noninfectious linearized DNA plasmids with CT and NG sequences in buffered solution with carrier DNA. Preservatives：Sodium azide and 0.15% ProClin 950. 8L07-90/2G28-91 Abbott RealTime CT/NG Amplification Reagent Kit\n1.Abbott RealTime CT/NG Internal Control\n< 0.01% noninfectious linearized DNA plasmid in a buffer solution with carrier DNA. Preservatives：Sodium azide and 0.15% ProClinR 950. 2.Abbott RealTime CT/NG Amplification Reagent Pack\n1 bottle (0.078 mL) AmpliTaq Gold Enzyme. (5.4 to 5.9 Units/μL) in a buffered solution with stabilizers.\n1 bottle (0.696 mL) Amplification Reagent. < 0.1% synthetic oligonucleotides (6 primers and 3 probes) and < 0.1% dNTPs in a buffered solution with a reference dye. Preservatives：Sodium azide and 0.15% ProClin 950.\n1 bottle (0.778 mL) Activation Reagent. 38mM magnesium chloride in a buffered solution. Preservatives：Sodium azide and 0.15% ProClin 950. 2.Sterile Specimen Collection Swab 3.Disposable Transfer Pipette 9K12-01/9K12-03 Abbott multi-Collect Specimen Collection Kit\n1.Transport Tube with Solid Cap containing 1.2 mL Specimen Transport Buffer (guanidine thiocyanate in Tris buffer)

製造商

ABBOTT MOLECULAR INC.

製造國

US

申請商

美商亞培股份有限公司台灣分公司

有效日期

2029/05/14

發證日期

2009/05/14

供應藥局

目前尚無登錄供應此品項的藥局資料。