Tissue plasminogen activator-inhibitor 1 composite detection test kit (chemiluminescence immunoassay) - NMPA Registration 苏械注准20242400017
Access comprehensive regulatory information for Tissue plasminogen activator-inhibitor 1 composite detection test 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20242400017 and owned by Getein Biotech, Inc.. The device was approved on January 05, 2024.
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It is used for in vitro quantitative detection of tissue plasminogen activator-inhibitor 1 complex (t-PAIC) content in human plasma or whole blood.
用于体外定量检测人体血浆或全血中组织型纤溶酶原激活剂-抑制剂1复合体（t-PAIC）的含量。
L1: streptavidin-coated magnetic particles, 2.50 mg/mL; Contains 0.1% Pleozin PC-300 preservative. L dry powder: calibrator L (5.0-15.0 ng/mL, t-PAIC (tissue plasminogen activator-inhibitor 1 complex) recombinant antigen, E. coli expression, 20 mM phosphate buffer, pH=7.4±0.2, with preservative 0.1% Plenigen PC-300) H dry powder: calibrator H (60-80 ng/mL, t-PAIC (tissue plasminogen activator-inhibitor 1 complex) recombinant antigen, E. coli expression, 20 mM phosphate buffer, pH=7.4±0.2, with preservative 0.1% Pleozin PC-300) L3: acridine ester-labeled t-PA monoclonal mouse antibody (1) (0.12-0.18 μg/mL), 100 mmol/L phosphate buffer, pH=6.96±0.2, containing 0.1% Pleozin PC-300 preservative. L4: Biotinylated PAI-1 monoclonal mouse antibody (2) (0.12-0.18 μg/mL), 100 mM phosphate buffer, pH=6.96±0.2, containing 0.1% Plepin PC-300 preservative. L5: Pretreatment reagent (100 mM phosphate buffer; pH=6.96±0.2).
L1：链霉亲和素包被的磁性微粒，2.50mg/mL； 含0.1%普乐净PC-300防腐剂。 L干粉：校准品L（5.0-15.0 ng/mL, t-PAIC（组织型纤溶酶原激活剂-抑制剂1复合体）重组抗原，大肠杆菌表达， 20mM磷酸盐缓冲液, pH=7.4±0.2，含防腐剂0.1% 普乐净PC-300） H干粉：校准品H（60-80 ng/mL, t-PAIC（组织型纤溶酶原激活剂-抑制剂1复合体）重组抗原，大肠杆菌表达， 20mM磷酸盐缓冲液, pH=7.4±0.2，含防腐剂0.1% 普乐净PC-300） L3：吖啶酯标记的t-PA单克隆小鼠抗体① (0.12-0.18 μg/mL)，100mmol/L磷酸盐缓冲液；pH=6.96±0.2；含0.1%普乐净PC-300防腐剂。 L4：生物素标记的PAI-1单克隆小鼠抗体② (0.12-0.18 μg/mL)，100mM磷酸盐缓冲液；pH=6.96±0.2；含0.1%普乐净PC-300防腐剂。 L5：预处理试剂（100mM磷酸盐缓冲液；pH=6.96±0.2）。
The unopened reagent is stored at 2~8 °C, and the validity period is 12 months; The open bottle of reagent is stored at 2~8 °C, and the validity period is 30 days; Immediately after opening, store in the reagent compartment at 8~14°C, and the validity period is 30 days. After the lyophilized components of this product are reconstituted, they should be stored at 2~8 °C in the dark, and the validity period is 15 days.
未开瓶试剂2~8℃保存，有效期为12个月； 开瓶试剂2~8℃保存，有效期为30天； 开瓶后立即于试剂仓8~14℃保存，有效期为30天。 本品冻干组分复溶后于2~8℃避光保存，有效期为15天。