亞培設計師葉酸檢驗試劑組
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名亞培設計師葉酸檢驗試劑組的英文品名是ABBOTT ARCHITECT Folate, 許可證字號是衛署醫器輸字第017543號, 有效日期是2026/09/28, 許可證種類是09, 效能是本產品用於在ARCHITECT i系統上,以化學冷光微粒葉酸結合蛋白質分析法定量檢測人類血清、血漿及紅血球中的葉酸(folate)。, 主成分略述是Reagent kit: Microparticles: 1 or 4 bottles anti-Folate binding protein coupled to microparticles affinity bound with Folate binding protein, in TRIS ..., 醫器規格是變更規格:1P-01/10/25/35/40/50/3P21-60規格變更(更正)為:1P74-01/10/25/35/40/50/3P21-60。規格(期望值)及標籤仿單變更為:詳如中文仿單核定本。(原99年3月18日標籤仿單核定本正本收回作廢)規格及標籤、說明書或包裝:詳如核定之中文說明書(原1..., 限制項目是輸 入, 申請商名稱是美商亞培股份有限公司台灣分公司.
許可證字號 | 衛署醫器輸字第017543號 |
註銷狀態 | (空) |
註銷日期 | (空) |
註銷理由 | (空) |
有效日期 | 2026/09/28 |
發證日期 | 2006/09/28 |
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 | DHA00601754300 |
中文品名 | 亞培設計師葉酸檢驗試劑組 |
英文品名 | ABBOTT ARCHITECT Folate |
效能 | 本產品用於在ARCHITECT i系統上,以化學冷光微粒葉酸結合蛋白質分析法定量檢測人類血清、血漿及紅血球中的葉酸(folate)。 |
劑型 | (空) |
包裝 | (空) |
醫器主類別一 | A 臨床化學及臨床毒理學 |
醫器次類別一 | A.1295 葉酸試驗系統 |
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 | Reagent kit: Microparticles: 1 or 4 bottles anti-Folate binding protein coupled to microparticles affinity bound with Folate binding protein, in TRIS buffer with protein stabilizers, antimicrobial agents. Conjugate: 1 or 4 bottles Pteroic acid (PTA)-acridinium labeled conjugate in MES buffer with protein stabilizer, antimicrobial agents. Assay specific diluent: 1 or 4 bottles containing borate buffer, antimicrobial agents. Pre-treatment reagent 1: 1 or 4 bottles containing potassium hydroxide. Pre-treatment reagent 2: 1 or 4 bottles containing dithiotheritol (DTT) in acetic acid buffer with EDTA. Specimen diluent: 1 or 4 bottles Folate specimen diluent containing TRIS buffer with protein stabilizer, sodium azide.Calibrators: 6 bottles of ARCHITECT Folate Calibrators. Calibrator A contains TRIS buffer. Calibrator B through F contain pteroylglutamic acid (PGA) in TRIS buffer. All calibrators contain protein stabilizer, sodium azide.5mTHF Low Controls: 8 bottles of ARCHITECT Folate 5mTHF Low Control. The control contains 5-methyltetrahydrofolic acid (5mTHF) in TRIS buffer with protein and anti-oxidant stabilizers, sodium azide.Controls: 3 bottles of ARCHITECT Folate Low, Medium and High Controls. Controls contain pteroylglutamic acid (PGA) in TRIS buffer with protein stabilizer, sodium azide.Manual Diluent: 1 bottle containing TRIS buffer with protein stabilizer, sodium azide.RBC Lysis Diluent: 1 bottle containing citric acid and guanidine hydrochloride, antimicrobial agent. |
醫器規格 | 變更規格:1P-01/10/25/35/40/50/3P21-60規格變更(更正)為:1P74-01/10/25/35/40/50/3P21-60。規格(期望值)及標籤仿單變更為:詳如中文仿單核定本。(原99年3月18日標籤仿單核定本正本收回作廢)規格及標籤、說明書或包裝:詳如核定之中文說明書(原106年5月3日核定之標籤、說明書或包裝正本收回作廢)。 |
限制項目 | 輸 入 |
申請商名稱 | 美商亞培股份有限公司台灣分公司 |
申請商地址 | 臺北市中山區民生東路3段49號5樓、6樓及51號6樓 |
申請商統一編號 | 30961216 |
製造商名稱 | ABBOTT IRELAND DIAGNOSTICS DIVISION |
製造廠廠址 | LISNAMUCK, LONGFORD, CO. LONGFORD, IRELAND |
製造廠公司地址 | (空) |
製造廠國別 | IE |
製程 | (空) |
異動日期 | 2023/07/31 |
製造許可登錄編號 | QSD5514 QSD5514 QSD5514 |
許可證字號衛署醫器輸字第017543號 |
註銷狀態(空) |
註銷日期(空) |
註銷理由(空) |
有效日期2026/09/28 |
發證日期2006/09/28 |
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DHA00601754300 |
中文品名亞培設計師葉酸檢驗試劑組 |
英文品名ABBOTT ARCHITECT Folate |
效能本產品用於在ARCHITECT i系統上,以化學冷光微粒葉酸結合蛋白質分析法定量檢測人類血清、血漿及紅血球中的葉酸(folate)。 |
劑型(空) |
包裝(空) |
醫器主類別一A 臨床化學及臨床毒理學 |
醫器次類別一A.1295 葉酸試驗系統 |
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Reagent kit: Microparticles: 1 or 4 bottles anti-Folate binding protein coupled to microparticles affinity bound with Folate binding protein, in TRIS buffer with protein stabilizers, antimicrobial agents. Conjugate: 1 or 4 bottles Pteroic acid (PTA)-acridinium labeled conjugate in MES buffer with protein stabilizer, antimicrobial agents. Assay specific diluent: 1 or 4 bottles containing borate buffer, antimicrobial agents. Pre-treatment reagent 1: 1 or 4 bottles containing potassium hydroxide. Pre-treatment reagent 2: 1 or 4 bottles containing dithiotheritol (DTT) in acetic acid buffer with EDTA. Specimen diluent: 1 or 4 bottles Folate specimen diluent containing TRIS buffer with protein stabilizer, sodium azide.Calibrators: 6 bottles of ARCHITECT Folate Calibrators. Calibrator A contains TRIS buffer. Calibrator B through F contain pteroylglutamic acid (PGA) in TRIS buffer. All calibrators contain protein stabilizer, sodium azide.5mTHF Low Controls: 8 bottles of ARCHITECT Folate 5mTHF Low Control. The control contains 5-methyltetrahydrofolic acid (5mTHF) in TRIS buffer with protein and anti-oxidant stabilizers, sodium azide.Controls: 3 bottles of ARCHITECT Folate Low, Medium and High Controls. Controls contain pteroylglutamic acid (PGA) in TRIS buffer with protein stabilizer, sodium azide.Manual Diluent: 1 bottle containing TRIS buffer with protein stabilizer, sodium azide.RBC Lysis Diluent: 1 bottle containing citric acid and guanidine hydrochloride, antimicrobial agent. |
醫器規格變更規格:1P-01/10/25/35/40/50/3P21-60規格變更(更正)為:1P74-01/10/25/35/40/50/3P21-60。規格(期望值)及標籤仿單變更為:詳如中文仿單核定本。(原99年3月18日標籤仿單核定本正本收回作廢)規格及標籤、說明書或包裝:詳如核定之中文說明書(原106年5月3日核定之標籤、說明書或包裝正本收回作廢)。 |
限制項目輸 入 |
申請商名稱美商亞培股份有限公司台灣分公司 |
申請商地址臺北市中山區民生東路3段49號5樓、6樓及51號6樓 |
申請商統一編號30961216 |
製造商名稱ABBOTT IRELAND DIAGNOSTICS DIVISION |
製造廠廠址LISNAMUCK, LONGFORD, CO. LONGFORD, IRELAND |
製造廠公司地址(空) |
製造廠國別IE |
製程(空) |
異動日期2023/07/31 |
製造許可登錄編號QSD5514 QSD5514 QSD5514 |
亞培設計師葉酸檢驗試劑組地圖 [ 導航 ]
亞培設計師葉酸檢驗試劑組的地址位於
臺北市中山區民生東路3段49號5樓、6樓及51號6樓