Treponema pallidum Antibody Test Kit (Colloidal Gold Method) - NMPA Registration 国械注准20243400580
Access comprehensive regulatory information for Treponema pallidum Antibody Test Kit (Colloidal Gold 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20243400580 and owned by Aikang Diagnostics Co., Ltd.. The device was approved on March 21, 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.
It is used for in vitro qualitative detection of treponema pallidum antibodies in human serum, plasma, or whole blood.
用于体外定性检测人血清、血浆或全血中的梅毒螺旋体抗体。
The kit consists of a reagent strip/card, desiccant, and sample diluent. (Please refer to the product manual for details)
试剂盒由试剂条/卡、干燥剂和样本稀释液组成。（具体内容详见产品说明书）
4~30 °C dry and protected from light, valid for 24 months.
4～30℃干燥避光保存，有效期24个月。