D-dimer (D-Dimer) controls - NMPA Registration 粤械注准20242401605
Access comprehensive regulatory information for D-dimer (D-Dimer) controls in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242401605 and owned by Guangzhou Wondfo BIOTECH Co., Ltd.. The device was approved on December 02, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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.
本产品适用于广州万孚生物技术股份有限公司生产的 D-二聚体(D-Dimer)测定试剂(干式荧光免疫一步法)及其适用仪器组成的检测系统,用于 D-二聚体(D-Dimer)检测项目的质量控制.
本产品适用于广州万孚生物技术股份有限公司生产的 D-二聚体（D-Dimer）测定试剂（干式荧光免疫一步法）及其适用仪器组成的检测系统，用于 D-二聚体（D-Dimer）检测项目的质量控制。
本产品为冻干粉,主要成分为 D-二聚体(D-Dimer)抗原(人源蛋白)、Tris-HCl 缓冲液、Proclin300.
本产品为冻干粉，主要成分为 D-二聚体（D-Dimer）抗原（人源蛋白）、Tris-HCl 缓冲液、Proclin300。
4℃～30℃密封避光保存,有效期为12个月.开盖复溶后在4℃～30℃可保存8小时,分装后可在-20℃条件下冻存28天,不可反复冻融.
4℃～30℃密封避光保存，有效期为12个月。开盖复溶后在4℃～30℃可保存8小时，分装后可在-20℃条件下冻存28天，不可反复冻融。