Mycobacterium tuberculosis-specific cell-mediated immune response detection kit (chemiluminescence method with magnetic microspheres)
- Device class
- Class III
- Model specifications
- 25 servings/box.25人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401207
- Approval date
- July 02, 2024
- Expiry date
- July 01, 2029
- Name
- Beijing BGI-GBI Biotech Co., Ltd.北京华大吉比爱生物技术有限公司
- Province/Region
- Beijing北京
- Address
- Room 236, Room 237, Building 1, No. 538, Yongfeng Tun, Haidian District, Beijing北京市海淀区永丰屯538号1号楼236、237室
- Production address
- 北京市顺义区临空经济核心区裕华路28号6号4层，8号2层西侧，12号3层西，12号1层西侧
This product is used for the qualitative detection of Mycobacterium tuberculosis-specific T cell immune response in human fresh peripheral venous anticoagulant blood.
本产品用于定性检测人新鲜外周静脉抗凝血中结核分枝杆菌特异性的T细胞免疫反应。
This product consists of a reagent package (magnetic particles, acridine ester marker), calibration solution 1, calibration solution 2, test culture tube, background control culture tube, positive control culture tube, and information card. (Please refer to the product manual for details)
本产品由试剂包（磁微粒、吖啶酯标记物）、定标液1、定标液2、测试培养管、本底对照培养管、阳性对照培养管，信息卡。（具体内容详见产品说明书）
2 °C ~ 8 °C storage, valid for 12 months.
2℃～8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Mycobacterium tuberculosis-specific cell-mediated immune response detection kit (chemiluminescence method with magnetic microspheres) 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20243401207 and owned by Beijing BGI-GBI Biotech Co., Ltd.. The device was approved on July 02, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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.