China NMPA legacy archive 鲁械注准20242401076Procalcitonin (PCT) Test Kit (Chemiluminescence Method with Magnetic Microparticles)
- Device class
- Class II
- Model specifications
- 1×50 servings/box, 2×50 servings/box, 1×100 servings/box, 2×100 servings/box.
- Approval department
- Shandong Provincial Drug Administration
- Registration number
- 鲁械注准20242401076
- Approval date
- December 09, 2024
- Expiry date
- December 08, 2029
- Province/Region
- Shandong
- Address
- No. 1-4, Weigao Road, Torch High-tech Industrial Development Zone, Weihai City, Shandong Province
- Production address
- 山东省威海临港经济技术开发区棋山路566号
用于体外定量检测人血清/血浆中的降钙素原含量.
用于体外定量检测人血清/血浆中的降钙素原含量。
测降钙素原磁微粒:含有1mg 磁微粒标记 20μg PCT 抗体的液体; 测降钙素原示踪结合物 :含有10mol 吖啶酯标记1mol PCT 抗体的溶液. 校准品1:含有低浓度 PCT 纯品的冻干疏松体,浓度有批特异性,其浓度通过扫描标签获得,浓度值不低于0.2ng/mL.; 校准品2:含有高浓度 PCT 纯品的冻干疏松体,浓度有批特异性,其浓度通过扫描标签获得,浓度值不低于2ng/mL. 质控品:含有一定浓度 PCT 纯品的冻干疏松体,浓度有批特异性,质控品浓度在0.05ng/mL-20ng/mL 范围内,具体范围见对应批号的标签.
测降钙素原磁微粒：含有1mg 磁微粒标记 20μg PCT 抗体的液体； 测降钙素原示踪结合物 ：含有10mol 吖啶酯标记1mol PCT 抗体的溶液。 校准品1：含有低浓度 PCT 纯品的冻干疏松体，浓度有批特异性，其浓度通过扫描标签获得，浓度值不低于0.2ng/mL。； 校准品2：含有高浓度 PCT 纯品的冻干疏松体，浓度有批特异性，其浓度通过扫描标签获得，浓度值不低于2ng/mL。 质控品：含有一定浓度 PCT 纯品的冻干疏松体，浓度有批特异性，质控品浓度在0.05ng/mL-20ng/mL 范围内，具体范围见对应批号的标签。
原装试剂盒于2~8℃避光保存,有效期14个月.
原装试剂盒于2~8℃避光保存，有效期14个月。
- Appendix
- 产品技术要求、说明书
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