Procalcitonin (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.1×50人份/盒、2×50人份/盒、1×100人份/盒、2×100人份/盒。
- Approval department
- Shandong Provincial Drug Administration山东省药品监督管理局
- Registration number
- 鲁械注准20242401076
- Approval date
- December 09, 2024
- Expiry date
- December 08, 2029
- Name
- Weihai Weigao BIOTECHNOLOGY Co., Ltd.威海威高生物科技有限公司
- Province/Region
- Shandong山东
- Address
- No. 1-4, Weigao Road, Torch High-tech Industrial Development Zone, Weihai City, Shandong Province山东省威海市火炬高技术产业开发区威高路1-4号
- 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
Access comprehensive regulatory information for Procalcitonin (PCT) Test Kit (Chemiluminescence Method with Magnetic Microparticles) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242401076 and owned by Weihai Weigao BIOTECHNOLOGY Co., Ltd.. The device was approved on December 09, 2024.
This page provides complete registration details including registrant information, province location (Shandong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.