Tissue plasminogen activator-inhibitor 1 composite detection test kit (chemiluminescence immunoassay)
- Device class
- Class II
- Model specifications
- 10 servings/box, 2×10 servings/box, 3×10 servings/box, 4×10 servings/box, 25 servings/box, 2×25 servings/box, 3×25 servings/box, 4×25 servings/box, 50 servings/box, 2×50 servings/box, 3×50 servings/box, 4×50 servings/box, 75 servings/box, 2×75 servings/box, 3×75 servings/box, 100 servings/box, 2×100 servings/box, 150 persons/box, 200 servings/box.
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20242400017
- Approval date
- January 05, 2024
- Expiry date
- January 04, 2029
- Province/Region
- Jiangsu
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing
- Production address
- 南京市六合区沿江工业开发区博富路9号,南京市江北新区科丰路6号
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。
- Appendix
- 产品技术要求、说明书
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