γ-Interferon Detection Kit (Chemiluminescence Immunoassay) - NMPA Registration 苏械注准20242401939
Access comprehensive regulatory information for γ-Interferon Detection Kit (Chemiluminescence Immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20242401939 and owned by Suzhou Lihe Biomedical Engineering Co., Ltd.. The device was approved on September 29, 2024.
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It is used for in vitro quantitative detection of the concentration of γ-interferon in human serum
用于体外定量检测人血清中γ-干扰素的浓度
Reagent 1: biotin-conjugated monoclonal antibody to γ-interferon (1) (approximately 0.5 mg/L, mouse derived), protein buffer (containing 1% bovine serum albumin, 0.1% Proclin300); Reagent 2: Acridine ester-conjugated monoclonal antibody to γ-interferon (2) (approximately 0.5 mg/L, murine derived), protein buffer (containing 1% bovine serum albumin, 0.1% Proclin300); Reagent M: Streptavidin-coated magnetic particles (approximately 0.3 mg/mL) with 0.1% Proclin300; Calibrator (1) (optional): protein buffer (containing 1% bovine serum protein, 0.1% preservative); Calibrator (2) (optional): containing γ-interferon antigen, (recombinant, E. coli, approx. 2.0 IU/mL) protein buffer (containing 1% bovine serum protein, 0.1% preservative); Calibrator (3) (optional): with γ-interferon antigen, (recombinant, E. coli, approx. 10.0 IU/mL), protein buffer (1% bovine serum protein, 0.1% preservative); Calibrator (4) (optional): with γ-interferon antigen, (recombinant, E. coli, approx. 50.0 IU/mL), protein buffer (1% bovine serum protein, 0.1% preservative); Calibrator (5) (optional): containing γ-interferon antigen, (recombinant, E. coli, approx. 500.0 IU/mL), protein buffer (containing 1% bovine serum protein, 0.1% preservative); Calibrator (6) (optional): with γ-interferon antigen, (recombinant, Escherichia coli, approx. 1000.0 IU/mL), protein buffer (with 1% bovine serum protein, 0.1% preservative); Control (1) (optional): with γ-interferon antigen, (recombinant, E. coli, approx. 10.00 IU/mL), bovine serum (0.1% preservative); Control (2) (optional): containing γ-interferon antigen, (recombinant, E. coli, approx. 500.00 IU/mL), bovine serum (0.1% preservative); 1 puncture tool: used for puncture of reagent bottle caps. QR code label: including reagent information, calibrator concentration, prefabricated calibration curve (calibrator 3 and calibrator 5 calibration and standard repair are used); Calibrator traceability: traceable to the γ-Interferon International Reference Material (NIBSC WHO code: 82/587).
试剂1：含生物素标记的γ-干扰素单克隆抗体①(约0.5mg/L，鼠源性)，蛋白缓冲液（含1%牛血清白蛋白，0.1% Proclin300）；试剂2：含吖啶酯标记的γ-干扰素单克隆抗体② (约0.5mg/L，鼠源性)，蛋白缓冲液（含1%牛血清白蛋白，0.1% Proclin300）；试剂M：含链霉亲和素包被的磁颗粒(约0.3mg/mL)，含0.1% Proclin300；校准品①（选配）：蛋白缓冲液（含1%牛血清蛋白，0.1%防腐剂）；校准品②（选配）：含γ-干扰素抗原，（重组，大肠杆菌，约2.0 IU/mL）蛋白缓冲液（含1%牛血清蛋白，0.1%防腐剂）；校准品③（选配）：含γ-干扰素抗原，（重组，大肠杆菌，约10.0 IU/mL），蛋白缓冲液（含1%牛血清蛋白，0.1%防腐剂）；校准品④（选配）：含γ-干扰素抗原，（重组，大肠杆菌，约50.0 IU/mL），蛋白缓冲液（含1%牛血清蛋白，0.1%防腐剂）；校准品⑤（选配）：含γ-干扰素抗原，（重组，大肠杆菌，约500.0 IU/mL），蛋白缓冲液（含1%牛血清蛋白，0.1%防腐剂）；校准品⑥（选配）：含γ-干扰素抗原，（重组，大肠杆菌，约1000.0 IU/mL），蛋白缓冲液（含1%牛血清蛋白，0.1%防腐剂）；质控品①（选配）：含γ-干扰素抗原，（重组，大肠杆菌，约10.00 IU/mL），牛血清（含0.1%防腐剂）；质控品②（选配）：含γ-干扰素抗原，（重组，大肠杆菌，约500.00 IU/mL），牛血清（含0.1%防腐剂）；刺穿工具1个：用于试剂瓶盖的穿刺使用。二维码标签：含试剂信息、校准品浓度、预制校准曲线（采用校准品3、校准品5校准修标）；校准品溯源性：溯源至γ-干扰素国际标准物质（NIBSC WHO code：82/587）。
Unopened reagents, calibrators and quality controls are stored at 2-8°C with an expiration date of 18 months; The opened reagent is stable for 60 days at 2-8°C. The reconstituted calibrator is stable for 8 hours at 2-8°C and 72 hours at 2-8°C.
未开封的试剂、校准品及质控品2-8℃环境下储存，有效期18个月；开封的试剂，2-8℃环境下可稳定保存60天。复溶后的校准品，2-8℃环境下可稳定保存8小时复溶后的质控品，2-8℃环境下可稳定保存72小时。