適應症
本試劑利用核酸檢測方式,提供低至中解析度的HLA-A、HLA-B及HLA-C之型別鑑定結果。  
劑型
 
包裝
#33200,#33210 新增規格:#33211。 
許可證字號
衛署醫器製字第002591號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2028-07-30  
發證日期
2008-07-30  
許可證種類
09 
中文品名
摩根人類主要組織相容性抗原分子專一引子片段 ABC 分型試劑 
英文品名
Morgan TM HLA SSP ABC Typing Kit 
藥品類別
B 血液學及病理學裝置 
申請商地址
臺北市南港區園區街3號14樓 
通關簽審文件編號
DHY00500259102 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
台塑生醫科技股份有限公司宜蘭廠 宜蘭縣礁溪鄉龍潭村龍泉路3號 TW
成份表
處方標示 成分名稱 含量 單位
1 33200 (A, B, C locus, 20 tests, 2 tests/tray)\nTyping Trays: Each tray is designed for 2 tests, consisting of PCR tubes that contain dried primers. A black dot marks the position one for each test. \n8M Buffer: The buffer is optimized for PCR reactions, and contains nucleotides, salts, glycerol and cresol red (final concentration: 0.2 mM dNTP, 2 mM MgCl2, 67 mM KCl, 21 mM Tris-HCl, 0.67 % glycerol). Each pre-aliquoted tube is for 1 test.\nPCR Sealing Film: The cover membrane is to cover the PCR plate to prevent evaporation loss of the buffer during the process.\nGel Interpretation Worksheets: The worksheet reveals the primer sets which are indicative of specific alleles.
1 33210 (A, B, C locus, 20 tests, 1 test/tray)\nTyping Trays: Each tray is designed for 1 test, consisting of PCR tubes that contain dried primers. A black dot marks the position one for each test. \nMaster Buffer: The buffer is optimized for PCR reactions, and contains nucleotides, salts, glycerol and cresol red (final concentration: 0.18 mM dNTP, 1.8 mM MgCl2, 60.3 mM KCl, 18.9 mM Tris-HCl, 0.6 % glycerol). Each pre-aliquoted tube is for 1 test.\nPCR Sealing Film: The cover membrane is to cover the PCR plate to prevent evaporation loss of the buffer during the process.\nGel Interpretation Worksheets: The worksheet reveals the primer sets which are indicative of specific alleles.