因諾瓦抗心脂質抗體免疫球蛋白 G 酵素連結免疫分析法檢驗系統
- 醫療器材許可證資料集 @ 衛生福利部食品藥物管理署
中文品名因諾瓦抗心脂質抗體免疫球蛋白 G 酵素連結免疫分析法檢驗系統的英文品名是QUANTA LiteTM ACA IgG III, 許可證字號是衛署醫器輸字第014983號, 有效日期是2025/11/24, 許可證種類是09, 效能是利用免疫酵素法進行人類血清檢體內之免疫球蛋白 G 抗心磷脂質抗體之半定量檢測。, 主成分略述是9.ACA Sample Diluent, 1 vial - containing PBS-buffered saline, protein stabilizers and preservative.\n10.ACA PBS Concentrate, 1 vial of 20x concentrat..., 醫器規格是# 708625。, 限制項目是輸 入, 申請商名稱是碩景股份有限公司.
#因諾瓦抗心脂質抗體免疫球蛋白 G 酵素連結免疫分析法檢驗系統的地圖
許可證字號 | 衛署醫器輸字第014983號 |
註銷狀態 | (空) |
註銷日期 | (空) |
註銷理由 | (空) |
有效日期 | 2025/11/24 |
發證日期 | 2005/11/24 |
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 | DHA00601498300 |
中文品名 | 因諾瓦抗心脂質抗體免疫球蛋白 G 酵素連結免疫分析法檢驗系統 |
英文品名 | QUANTA LiteTM ACA IgG III |
效能 | 利用免疫酵素法進行人類血清檢體內之免疫球蛋白 G 抗心磷脂質抗體之半定量檢測。 |
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 | 9.ACA Sample Diluent, 1 vial - containing PBS-buffered saline, protein stabilizers and preservative.\n10.ACA PBS Concentrate, 1 vial of 20x concentrate - colored red containing PBS-buffered saline.\n11.HRP IgG Conjugate, (goat), anti-human IgG, 1 vial - colored blue containing buffer, protein stabilizers and preservative.\n12.TMB Chromogen, 1 vial containing stabilizers.\n13.HRP Stop Solution, 0.344M Sulfuric Acid. Reagents\n1.Polystyrene microwell ELISA plate coated with a purified cardiolipin antigen as well as both bovine and human β2 GPI (12-1 x 8 wells).\n2.ACA Negative Control, 1 vial of buffer containing preservative and human serum with no human antibodies to cardiolipin.\n3.ACA HRP IgG Control, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n4.ACA HRP IgG Control A, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n5.ACA HRP IgG Control B, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n6.ACA HRP IgG Control C, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n7.ACA HRP IgG Control D, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n8.ACA HRP IgG Control E, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n |
醫器規格 | # 708625。 |
限制項目 | 輸 入 |
申請商名稱 | 碩景股份有限公司 |
申請商地址 | 臺北市信義區松德路74號8樓 |
申請商統一編號 | 80672330 |
製造商名稱 | INOVA DIANOSTICS, INC. |
製造廠廠址 | 9900 OLD GROVE ROAD, SAN DIEGO, CA 92131 U.S.A. |
製造廠公司地址 | (空) |
製造廠國別 | US |
製程 | (空) |
異動日期 | 2020/08/17 |
製造許可登錄編號 | QSD14865 |
許可證字號衛署醫器輸字第014983號 |
註銷狀態(空) |
註銷日期(空) |
註銷理由(空) |
有效日期2025/11/24 |
發證日期2005/11/24 |
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DHA00601498300 |
中文品名因諾瓦抗心脂質抗體免疫球蛋白 G 酵素連結免疫分析法檢驗系統 |
英文品名QUANTA LiteTM ACA IgG III |
效能利用免疫酵素法進行人類血清檢體內之免疫球蛋白 G 抗心磷脂質抗體之半定量檢測。 |
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9.ACA Sample Diluent, 1 vial - containing PBS-buffered saline, protein stabilizers and preservative.\n10.ACA PBS Concentrate, 1 vial of 20x concentrate - colored red containing PBS-buffered saline.\n11.HRP IgG Conjugate, (goat), anti-human IgG, 1 vial - colored blue containing buffer, protein stabilizers and preservative.\n12.TMB Chromogen, 1 vial containing stabilizers.\n13.HRP Stop Solution, 0.344M Sulfuric Acid. Reagents\n1.Polystyrene microwell ELISA plate coated with a purified cardiolipin antigen as well as both bovine and human β2 GPI (12-1 x 8 wells).\n2.ACA Negative Control, 1 vial of buffer containing preservative and human serum with no human antibodies to cardiolipin.\n3.ACA HRP IgG Control, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n4.ACA HRP IgG Control A, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n5.ACA HRP IgG Control B, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n6.ACA HRP IgG Control C, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n7.ACA HRP IgG Control D, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n8.ACA HRP IgG Control E, 1 vail of buffer containing preservative and human serum antibodies to cardiolipin.\n |
醫器規格# 708625。 |
限制項目輸 入 |
申請商名稱碩景股份有限公司 |
申請商地址臺北市信義區松德路74號8樓 |
申請商統一編號80672330 |
製造商名稱INOVA DIANOSTICS, INC. |
製造廠廠址9900 OLD GROVE ROAD, SAN DIEGO, CA 92131 U.S.A. |
製造廠公司地址(空) |
製造廠國別US |
製程(空) |
異動日期2020/08/17 |
製造許可登錄編號QSD14865 |
因諾瓦抗心脂質抗體免疫球蛋白 G 酵素連結免疫分析法檢驗系統地圖 [ 導航 ]
因諾瓦抗心脂質抗體免疫球蛋白 G 酵素連結免疫分析法檢驗系統的地址位於
臺北市信義區松德路74號8樓