Tuberculosis complex nucleic acid detection kit (PCR-fluorescence probe method)
- Device class
- Class III
- Model specifications
- 20 servings/box20人份/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20163402584
- Approval date
- October 20, 2021
- Expiry date
- December 28, 2026
- Name
- Shanghai Fosun LONG March MEDICAL Science Co., Ltd.复星诊断科技（上海）有限公司
- Province/Region
- Shanghai上海
- Address
- 830 Chengyin Road, Baoshan District, Shanghai上海市宝山区城银路830号
- Production address
- 上海市宝山区城银路830号
This product is used for in vitro qualitative detection of mycobacterium tuberculosis complex nucleic acid in human sputum samples.
本产品用于体外定性检测人痰液样本中的结核分枝杆菌复合群核酸。
DNA extract, PCR buffer, DNA polymerase, fluorescent probe, magnesium chloride, negative control, positive control No. 1, positive control No. 2, positive control No. 3. (Please refer to the manual for details)
DNA提取液、PCR缓冲液、DNA聚合酶、荧光探针、氯化镁、阴性对照、阳性对照1号、阳性对照2号、阳性对照3号。（具体内容详见说明书）
Store at -20°C, valid for 12 months.
﹣20℃保存，有效期12个月。
- Remark
- 延续注册产品技术要求未发生变化，沿用原核发的产品技术要求。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Tuberculosis complex nucleic acid detection kit (PCR-fluorescence probe 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20163402584 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on October 20, 2021.
This page provides complete registration details including registrant information, province location (Shanghai), 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.