Human Papillomavirus (HPV) Nucleic Acid Detection and 16/18 Typing Kit (Fluorescent PCR)
- Device class
- Class III
- Model specifications
- 1 serving/box, 3 servings/box, 6 servings/box, 12 servings/box, 24 servings/box, 48 servings/box, 96 servings/box1人份/盒、3人份/盒、6人份/盒、12人份/盒、24人份/盒、48人份/盒、96人份/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243400146
- Approval date
- January 18, 2024
- Expiry date
- January 17, 2029
- Name
- Getein Biotech, Inc.基蛋生物科技股份有限公司
- Province/Region
- Jiangsu江苏
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing南京市六合区沿江工业开发区博富路9号
- Production address
- 南京市六合区沿江工业开发区博富路9号；南京市江北新区科丰路6号
This kit was used to qualitatively detect the DNA of human papillomavirus (HPV) types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 in human cervical exfoliated cells, and the 16 and 18 types were typed and detected.
本试剂盒体外定性检测人宫颈脱落细胞中人乳头瘤病毒（Human papillomavirus，HPV）16型、18型、31型、33型、35型、39型、45型、51型、52型、56型、58型、59型、66型及68型的DNA，并对其中的16型和18型进行分型检测。
HPV Test Card, HPV Positive Control, HPV negative control, cell preservation solution, cervical sampler. (Please refer to the product manual for details)
HPV检测卡、 HPV阳性对照品、 HPV阴性对照品、细胞保存液、宫颈采样器。（具体内容详见产品说明书）
Store at 2~28°C in the dark, valid for 12 months.
2～28℃避光储存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Human Papillomavirus (HPV) Nucleic Acid Detection and 16/18 Typing Kit (Fluorescent PCR) 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20243400146 and owned by Getein Biotech, Inc.. The device was approved on January 18, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.