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

醫療器材許可證 · 許可證字號：衛署醫器輸字第021549號

許可證字號

衛署醫器輸字第021549號

註銷狀態

已註銷

註銷日期

2022/05/19

註銷理由

自行鍵入

有效日期

2020/09/24

發證日期

2010/09/24

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00602154901

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

效能

用來鑑別及分型人類第二型白血球抗原的器材。

醫器主類別一

B 血液學、病理學及基因學

醫器次類別一

B.0001 人類白血球抗原分型試驗系統

主成分略述

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 Buf…展開

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收合

醫器規格

▪ 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 …展開

▪ 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.收合

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輸 入

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

申請商統一編號

16799488

製造商名稱

LIFE TECHNOLOGIES CORPORATION

製造廠廠址

9099 North Deerbrook Trail Brown Deer, Wisconsin 53223

製造廠國別

US

異動日期

2022/05/25

製造許可登錄編號

QSD4921

建立時間 2026-09-22 15:59:33 · 更新時間 2026-09-22 15:59:33