Treponema pallidum Antibody Test Kit (Colloidal Gold Method)
- Device class
- Class III
- Model specifications
- Strip type: 25 servings/box, 50 servings/box, 100 servings/box. Cassette: 25 servings/box, 50 servings/box, 100 servings/box.条式：25人份/盒、50人份/盒、100人份/盒。卡式：25人份/盒、50人份/盒、100人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243400580
- Approval date
- March 21, 2024
- Expiry date
- March 20, 2029
- Name
- Aikang Diagnostics Co., Ltd.深圳市爱康试剂有限公司
- Province/Region
- Guangdong广东
- Address
- 401-1201, Building 1, iKang Biotechnology, No. 66 Juqing Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen深圳市坪山区坑梓街道金沙社区聚青路66号爱康生物1号楼401-1201
- Production address
- 深圳市龙华区观澜街道新澜社区观光路1303号鸿信工业园3号厂房501；1号厂房501
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。
- Changes
- 2024-03-27 变更注册证载明的生产地址由深圳市龙华区观澜街道新澜社区观光路1303号鸿信工业园3号厂房501；1号厂房501;变更为：深圳市坪山区坑梓街道金沙社区聚青路66号爱康生物1号楼整栋（2楼、3楼除外）
- Appendix
- 产品技术要求、说明书
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.