Hepatitis B virus surface antigen test kit (magnetic particle chemiluminescence method) - NMPA Registration 国械注准20243402639
Access comprehensive regulatory information for Hepatitis B virus surface antigen test kit (magnetic particle chemiluminescence method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243402639 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on December 23, 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.
本试剂用于体外定量测定人血清样本中的乙型肝炎病毒表面抗原的含量.
本试剂用于体外定量测定人血清样本中的乙型肝炎病毒表面抗原的含量。
磁性微球溶液、示踪物结合物、校准品C1、C2、质控品Q1、Q2.(具体内容详见产品说明书)
磁性微球溶液、示踪物结合物、校准品C1、C2、质控品Q1、Q2。（具体内容详见产品说明书）
Store at 2~8°C, valid for 18 months.
2~8℃保存，有效期18个月。