Treponema pallidum antibody detection reagent kit (chemiluminescent immunoassay) - NMPA Registration 国械注准20253400094
Access comprehensive regulatory information for Treponema pallidum antibody detection reagent kit (chemiluminescent immunoassay) 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20253400094 and owned by Aikang Diagnostics Co., Ltd.. The device was approved on January 10, 2025.
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.
本产品用于体外定性检测人血清或血浆样本中梅毒螺旋体抗体。
磁微粒（R1）、酶标记物（R2）、生物素标记物（R3）、对照品1、对照品2、质控品1、质控品2。（具体内容详见产品说明书）
Store at 2~8 °C in the dark, valid for 12 months.
2~8℃避光储存，有效期12个月。