伊姆諾康塞斯特螢光自體抗核抗體測定組
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名伊姆諾康塞斯特螢光自體抗核抗體測定組的英文品名是Immuno Concepts Fluorescent HEp-2 & HEp-2000 ANA Test Kit, 許可證字號是衛署醫器輸字第016152號, 有效日期是2016/03/15, 註銷狀態是已註銷, 註銷日期是2018/05/10, 註銷理由是許可證已逾有效期, 許可證種類是09, 效能是利用間接螢光抗體測定法半定量測定人類血清中的自體抗核抗體。, 主成分略述是Counterstain (Hep-2 ANA Test Kit only): Catalog No. 1105. Ready-to-use dropper vial containing 5.0 ml Evans blue solution (0.5% in PBS).\n\nNON-REACTI..., 醫器規格是#2200-RO，#2200-14-RO，#2200，以下空白。, 限制項目是輸 入, 申請商名稱是泓展有限公司.
| 許可證字號 | 衛署醫器輸字第016152號 |
| 註銷狀態 | 已註銷 |
| 註銷日期 | 2018/05/10 |
| 註銷理由 | 許可證已逾有效期 |
| 有效日期 | 2016/03/15 |
| 發證日期 | 2006/03/15 |
| 許可證種類 | 09 |
| 舊證字號 | (空) |
| 醫療器材級數 | 2 |
| 通關簽審文件編號 | DHA00601615206 |
| 中文品名 | 伊姆諾康塞斯特螢光自體抗核抗體測定組 |
| 英文品名 | Immuno Concepts Fluorescent HEp-2 & HEp-2000 ANA Test Kit |
| 效能 | 利用間接螢光抗體測定法半定量測定人類血清中的自體抗核抗體。 |
| 劑型 | (空) |
| 包裝 | (空) |
| 醫器主類別一 | C 免疫學及微生物學 |
| 醫器次類別一 | C.5100 抗核抗體免疫試驗系統 |
| 醫器主類別二 | (空) |
| 醫器次類別二 | (空) |
| 醫器主類別三 | (空) |
| 醫器次類別三 | (空) |
| 主成分略述 | Counterstain (Hep-2 ANA Test Kit only): Catalog No. 1105. Ready-to-use dropper vial containing 5.0 ml Evans blue solution (0.5% in PBS).\n\nNON-REACTIVE REAGENTS\n\nPBS Buffer Powder: Catalog No. 1011. Phosphate-buff- ered saline powder (0.01 M, pH 7.4 ± 0.2). \n\n\nSemi-Permanent Mounting Medium: Catalog No. 1111. Ready-to-use dropper vial containing 5.0 ml glycerol- based mounting medium, pH 9.1 ± 0.2. \n\nCoverslips: Catalog No. 1041. Each packet contains ten 24x60 mm No. 1 glass coverslips.\n\n Homogeneous Positive Control: Catalog No. 2021. Ready-to-use dropper vial containing 1.0 ml positive human control serum with antibody specific to DNA and/or DNP nuclear antigens. \n\nSpeckled Positive Control: Catalog No. 2022. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to Sm and/or RNP nuclear antigens. \n\nNucleolar Positive Control: Catalog No. 2023. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to nucleolar antigens. \n\nCentromere Positive Control: Catalog No. 2025. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to chromosomal centromeres (kinetochore). \n\nTitratable Control Serum: Catalog No. 2026. Ready-to- use vial containing 1.0 ml positive human control serum to be treated as an undiluted patient sample. \n\nNegative Control Serum: Catalog No. 2031. Ready-\nto-use dropper vial containing 1.0 ml negative human control serum.\n\nFlu Substrate Slides: Catalog No. 2007 (seven-well); 2013\n(thirteen-well): HEp-2 cells (with mitotic figures) grown and stabilized directly on the test wells. \n\nCatalog No. 2007-Ro (seven-well);\n2013-Ro (thirteen-well): HEp-2000R cells (with mitotic\nfigures) grown and stabilized directly on the test wells.\nThese are HEp-2 cells that have been stably transfected\nwith the SSA/Ro autoantigen. \n\nSSA/Ro Positive Control(Hep-2000 ANA Test Kit only)\n: Catalog No. 2035-Ro. Ready-to-use dropper vial containing \n1.0 ml positive human control serum with antibody specific to SSA/Ro antigens.\n\n |
| 醫器規格 | #2200-RO，#2200-14-RO，#2200，以下空白。 |
| 限制項目 | 輸 入 |
| 申請商名稱 | 泓展有限公司 |
| 申請商地址 | 台北市中山區敬業一路１６０號７樓 |
| 申請商統一編號 | 12554363 |
| 製造商名稱 | IMMUNO CONCEPTS NA LTD |
| 製造廠廠址 | 9825 Goethe Road #350, Sacramento, California 95827, U.S.A. |
| 製造廠公司地址 | (空) |
| 製造廠國別 | US |
| 製程 | (空) |
| 異動日期 | 2018/05/11 |
| 製造許可登錄編號 | QSD5999 |
許可證字號衛署醫器輸字第016152號 |
註銷狀態已註銷 |
註銷日期2018/05/10 |
註銷理由許可證已逾有效期 |
有效日期2016/03/15 |
發證日期2006/03/15 |
許可證種類09 |
舊證字號(空) |
醫療器材級數2 |
通關簽審文件編號DHA00601615206 |
中文品名伊姆諾康塞斯特螢光自體抗核抗體測定組 |
英文品名Immuno Concepts Fluorescent HEp-2 & HEp-2000 ANA Test Kit |
效能利用間接螢光抗體測定法半定量測定人類血清中的自體抗核抗體。 |
劑型(空) |
包裝(空) |
醫器主類別一C 免疫學及微生物學 |
醫器次類別一C.5100 抗核抗體免疫試驗系統 |
醫器主類別二(空) |
醫器次類別二(空) |
醫器主類別三(空) |
醫器次類別三(空) |
主成分略述Counterstain (Hep-2 ANA Test Kit only): Catalog No. 1105. Ready-to-use dropper vial containing 5.0 ml Evans blue solution (0.5% in PBS).\n\nNON-REACTIVE REAGENTS\n\nPBS Buffer Powder: Catalog No. 1011. Phosphate-buff- ered saline powder (0.01 M, pH 7.4 ± 0.2). \n\n\nSemi-Permanent Mounting Medium: Catalog No. 1111. Ready-to-use dropper vial containing 5.0 ml glycerol- based mounting medium, pH 9.1 ± 0.2. \n\nCoverslips: Catalog No. 1041. Each packet contains ten 24x60 mm No. 1 glass coverslips.\n\n Homogeneous Positive Control: Catalog No. 2021. Ready-to-use dropper vial containing 1.0 ml positive human control serum with antibody specific to DNA and/or DNP nuclear antigens. \n\nSpeckled Positive Control: Catalog No. 2022. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to Sm and/or RNP nuclear antigens. \n\nNucleolar Positive Control: Catalog No. 2023. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to nucleolar antigens. \n\nCentromere Positive Control: Catalog No. 2025. Ready- to-use dropper vial containing 0.5 ml positive human control serum with antibody specific to chromosomal centromeres (kinetochore). \n\nTitratable Control Serum: Catalog No. 2026. Ready-to- use vial containing 1.0 ml positive human control serum to be treated as an undiluted patient sample. \n\nNegative Control Serum: Catalog No. 2031. Ready-\nto-use dropper vial containing 1.0 ml negative human control serum.\n\nFlu Substrate Slides: Catalog No. 2007 (seven-well); 2013\n(thirteen-well): HEp-2 cells (with mitotic figures) grown and stabilized directly on the test wells. \n\nCatalog No. 2007-Ro (seven-well);\n2013-Ro (thirteen-well): HEp-2000R cells (with mitotic\nfigures) grown and stabilized directly on the test wells.\nThese are HEp-2 cells that have been stably transfected\nwith the SSA/Ro autoantigen. \n\nSSA/Ro Positive Control(Hep-2000 ANA Test Kit only)\n: Catalog No. 2035-Ro. Ready-to-use dropper vial containing \n1.0 ml positive human control serum with antibody specific to SSA/Ro antigens.\n\n |
醫器規格#2200-RO，#2200-14-RO，#2200，以下空白。 |
限制項目輸 入 |
申請商名稱泓展有限公司 |
申請商地址台北市中山區敬業一路１６０號７樓 |
申請商統一編號12554363 |
製造商名稱IMMUNO CONCEPTS NA LTD |
製造廠廠址9825 Goethe Road #350, Sacramento, California 95827, U.S.A. |
製造廠公司地址(空) |
製造廠國別US |
製程(空) |
異動日期2018/05/11 |
製造許可登錄編號QSD5999 |
伊姆諾康塞斯特螢光自體抗核抗體測定組地圖 [ 導航 ]
伊姆諾康塞斯特螢光自體抗核抗體測定組的地址位於
台北市中山區敬業一路１６０號７樓