Calcitonin test kit (latex-enhanced immunoturbidimetric assay) - NMPA Registration 渝械注准20202400110
Access comprehensive regulatory information for Calcitonin test kit (latex-enhanced immunoturbidimetric assay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20202400110 and owned by Chongqing Zhongyuan BIO-TECHNOLOGY Co., Ltd.. The device was approved on October 15, 2021.
This page provides complete registration details including registrant information, province location (Chongqing), 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.
The kit's performance has been validated on the Beckman AU480 automated biochemistry analyzer. For other models, please use after verification.
本试剂盒性能在贝克曼AU480全自动生化分析仪上经过验证。其它机型请经过验证后使用。
Reagent R1: Trimethylolaminomethane (Tris) buffer 100 mmol/L Reagent R2: Murine anti-human procalcitonin antibody latex granule suspension 0.1% Calibrator: Recombinant procalcitonin The labeled values are shown in the bottle label 3-(N-morpholine)propanesulfonic acid (MOPS) buffer 10mmol/L Controls: Recombinant procalcitonin The labeled values are shown in the bottle label 3-(N-morpholine)propanesulfonic acid (MOPS) buffer 10mmol/L Calibrators are traced back to corporate standards. Components in different lot sizes are not interchangeable.
试剂R1： 三羟甲基氨基甲烷（Tris）缓冲液 100mmol/L 试剂R2： 鼠抗人降钙素原抗体胶乳颗粒悬液 0.1% 校准品： 重组降钙素原 标示值见瓶签 3-(N-吗啡啉)丙磺酸(MOPS)缓冲液 10mmol/L 质控品： 重组降钙素原 标示值见瓶签 3-(N-吗啡啉)丙磺酸(MOPS)缓冲液 10mmol/L 校准品定值溯源至企业标准。 不同批号试剂盒中各组份不能互换。
1. The kit should be stored at 2~8 °C in the dark, and should not be frozen. The product is valid for 12 months. 2. After opening, store at 2~8 °C, can be stable for 4 weeks, please cover the reagent cover when not in use to avoid pollution. To ensure the accuracy of the results, calibrators and controls can only be used on the same day after reconstitution.
1、试剂盒应2～8℃避光贮存，不得冻存。产品有效期为12个月。 2、开封后，在2～8℃下贮存，可稳定4周，不使用时请盖好试剂盖，避免污染。为确保结果准确性，校准品、质控品复溶后仅限当天使用。