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Legacy registrant archive

Getein Biotech, Inc.

基蛋生物科技股份有限公司
JiangsuChina NMPA245 archived records
Static archiveNMPA · legacy registration snapshot
245
Archived records
2
Device classes
2019
Earliest approval
2025
Latest approval
Company overview
Archived records
245
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
Registration timeline
Earliest approval
Jun 17, 2019
Latest approval
Jan 20, 2025
Regulatory footprint
Search Getein Biotech, Inc. across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Device class distribution
Breakdown of 245 devices by regulatory classification
Class II21889.0% of total
Class III2711.0% of total
Archived records (10 most recent shown)
Click on any device for detailed registration information
乙型肝炎病毒核心抗体定量检测试剂盒（化学发光免疫分析法）
Jan 20, 2025
Registration number
国械注准20253400208
Class
Class III
Expiry date
Jan 19, 2030
异常凝血酶原检测试剂盒(化学发光免疫分析法)
异常凝血酶原检测试剂盒（化学发光免疫分析法）
Nov 27, 2024
Registration number
国械注准20243402400
Class
Class III
Expiry date
Nov 26, 2029
Influenza A/B virus and respiratory syncytial virus nucleic acid combined detection kit (fluorescence PCR method)
甲型/乙型流感病毒及呼吸道合胞病毒核酸联合检测试剂盒（荧光PCR法）
Sep 10, 2024
Registration number
国械注准20243401718
Class
Class III
Expiry date
Sep 09, 2029
Pepsinogen I/Pepsinogen II Assay Kit (Fluorescence Immunochromatography)
胃蛋白酶原I/胃蛋白酶原II测定剂盒（荧光免疫层析法）
Aug 30, 2024
Registration number
苏械注准20242401739
Class
Class II
Expiry date
Aug 29, 2029
血管紧张素Ⅰ测定试剂盒（化学发光免疫分析法）
May 31, 2024
Registration number
苏械注准20242401204
Class
Class II
Expiry date
May 30, 2029
血管紧张素II测定试剂盒（化学发光免疫分析法）
May 23, 2024
Registration number
苏械注准20242401142
Class
Class II
Expiry date
May 22, 2029
Alpha-fetoprotein detection kit (fluorescence immunochromatography)
甲胎蛋白检测试剂盒（荧光免疫层析法）
Mar 26, 2024
Registration number
国械注准20243400590
Class
Class III
Expiry date
Mar 25, 2029
Fully automated nucleic acid amplification analyzer
全自动核酸扩增分析仪
Feb 21, 2024
Registration number
国械注准20243220377
Class
Class III
Expiry date
Feb 20, 2029
Human Papillomavirus (HPV) Nucleic Acid Detection and 16/18 Typing Kit (Fluorescent PCR)
人乳头瘤病毒（HPV）核酸检测及16/18分型试剂盒（荧光PCR法）
Jan 18, 2024
Registration number
国械注准20243400146
Class
Class III
Expiry date
Jan 17, 2029
Tissue plasminogen activator-inhibitor 1 composite detection test kit (chemiluminescence immunoassay)
组织型纤溶酶原激活剂-抑制剂1复合体检测试剂盒（化学发光免疫分析法）
Jan 05, 2024
Registration number
苏械注准20242400017
Class
Class II
Expiry date
Jan 04, 2029
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About this profile

This static archive contains 245 records under the historical name Getein Biotech, Inc.. It does not establish the company's complete current portfolio or current authorization status.

Historical English translations and official Chinese names can differ. These archived names are not automatically equated with a holder in the current domestic-registration listing.