Q 熱非直接免疫螢光抗體試驗--IgG(未滅菌)
Q Fever IFA IgG (Non-Sterile)

適應症
偵測和定量人類IgG抗體對第Ⅰ，第Ⅱ時期Coxiella burnetii抗原的反應，同時幫助診斷Q Fever。  
劑型
 
包裝
IF0200G,以下空白。 
許可證字號
44000982 
註銷狀態
1 
註銷日期
2022-06-16  
註銷理由
888 
有效日期
2020-10-17  
發證日期
2005-10-17  
許可證種類
09 
中文品名
Q 熱非直接免疫螢光抗體試驗--IgG(未滅菌) 
英文品名
Q Fever IFA IgG (Non-Sterile) 
藥品類別
C 免疫學及微生物學裝置 
申請商名稱
豐技生物科技股份有限公司  
申請商地址
台北市中正區紹興北街5號5樓之1 
通關簽審文件編號
DHA04400098205 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY, CYPRESS, CALIFORNIA 90630, U.S.A. US
成份表
處方標示 成分名稱 含量 單位
1 Q Fever Substrate Slides:Ten slides of eight wells each. Each well contains 2 individual antigen sports: one inactivated C. burnetii phase I antigen spot and one inactivated C. burnetii phase II antigen spot.IgG Conjugate: One vial of affinity-purified and fluorescein-labeled goat anti-human IgG, gamma-chain specific. Contains Evan’s Blue counterstain, protein stabilizer and non-azide preservatives.Q Fever IgG Positive Control: One vial of human serum bottled at screening dilution. Contains non-azide preservatives.Q Fever IgG Negative Control: One vial of human serum bottled at screening dilution. Contains non-azide preservatives.IgG Sample Diluent (5X): One vial containing protein-based concentrate in goat serum, with non-azide preservatives.Mounting Medium: One dropper bottle containing PBS-buffered glycerol at a pH of 7.2 ± 0.1 Contains non-azide preservatives.PBS: One vial of phosphate buffered saline (PBS) powder. Reconstitute with 1 Liter distilled (or purified) water.