CA 15-3 放射免疫分析檢驗試劑

CA 15-3 Radio Immunoassay

衛署醫器輸字第013176號

本站收錄狀態已註銷

有效日期2015 / 10 / 13

醫療器材級數第二等級

這張許可證已註銷（2018/07/31，未展延而逾期者），以下僅供查閱歷史資料。申請商為 汎英股份有限公司。以下整理許可證、規格與製造廠資料，供核對產品身分使用。

許可證資料依公開資料欄位整理

效能: 定量DF3 antibody-defined antigen。
規格: 100 tests/kit
主成分: Reagents:
1 COATED BEADS:
CA 15-3 115D8 (murine monoclonal antibody) Coated Beads, 1 vial, containing 100 beads.
2 STANDARD/DILUENT:
CA 15-3 0 U/mL Standard/Diluent (buffered protein solution with preservative), 0 U/mL*, 1 vial, containing 100 mL.
3 STANDARDS:
CA 15-3 Standards (antigen diluted in a buffered protein solution containing preservative), prediluted to 25, 50, 100, 200 U/mL, 4 vials containing 1.2 mL each. Concentration of each standard is indicated on the vial.
4 Control:
CA 15-3 positive Control (with preservative), diluted re-calcified human plasma. Concentration and range of the control are indicated on the vial.
5 TRACER:
CA 15-3 125I-DF3 (murine monoclonal antibody), in TRIS buffer with protein stabilizers and preservative, 2 vials (10 mL each). Maximum radioactivity: 1.0 μCi/mL (37.1 kBq/mL).

可改用包裝上的完整型號或許可證字號查詢。