適應症
用來鑑別及分型人類第二型白血球抗原的器材。  
劑型
 
包裝
▪ 型號/規格/品名:54370D (20tests/Kit) AllSet Gold SSP HLA-DR Low Res. Kit54380D (20tests/Kit) AllSet Gold SSP HLA-DRDQ Low Res. Kit54390D (20tests/Kit) AllSet Gold SSP HLA-DQ Low Res. Kit▪ Product Packaged:Product components include the sequence specific primer mixes, PCR Buffer GL.The primer mixes overlaid with paraffin oil, are packaged in an adhesively sealed 96-well polycarbonate tray. The tray is packaged in a heat sealable foil pouch. The PCR Buffer GL is packaged in 0.5ml or 2.0ml polypropylene tubes, dependent upon the volume necessary for the test. These tubes are placed into a small box and the pouched trays and boxes are packaged together into a large box, which the whole makes up a kit. 
許可證字號
衛部藥製字第021549號 
註銷狀態
註銷日期
2022-05-19  
註銷理由
888 
有效日期
2020-09-24  
發證日期
2010-09-24  
許可證種類
09 
中文品名
英傑核酸引子式低解析人類白血球抗原第二型分型試驗系統 
英文品名
Invitrogen AllSet Gold SSP Class Ⅱ HLA Low Resolution Typing Kit 
藥品類別
B 血液學及病理學裝置 
申請商名稱
康奈爾股份有限公司  
申請商地址
新北市蘆洲區集賢路393號4樓 
通關簽審文件編號
DHA00602154901 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
LIFE TECHNOLOGIES CORPORATION 9099 North Deerbrook Trail Brown Deer, Wisconsin 53223 US
成份表
處方標示 成分名稱 含量 單位
1 Components:\n1. 96well polycarbonate PCR trays containing 5µl/well of optimized primer solution overlaid with paraffin oil. / Quantity: 2 to 10 trays (kit dependent)\n2. 75-580µl aliquots of optimized PCR Buffer containing dNTPs and Gel Loading Buffer. \n / Quantity: 10 - 40 vials (kit dependent)\n3. Plastic sealers for sealing PCR trays. / Quantity: 3 - 11 (kit dependent)\n4. Gel Documentation Form. / Quantity: 10 - 40 (kit dependent)\n5. Worksheets. / Quantity: 11 - 41 (kit dependent)\n6. Primer Mix Specificity Table. / Quantity: 1\n7. Certificate of Analysis/Tray Configuration. / Quantity: 1\n