A qualitative test kit for detecting and genotyping 15 types of human papillomavirus (HPV) DNA in cervical exfoliative cells or urine samples using fluorescent PCR methodology. The kit can identify and differentiate HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and 73.
Manufactured by
China
Xenta Biomedical Science Co., Ltd, founded in December 2021 and headquartered in Guangzhou Development District, is a national high-tech enterprise focused on the R&D, registration, and commercialization of in vitro diagnostic (IVD) reagents and devices. With fully paid-up capital of RMB 10 million, the company is led by a team of returnee PhDs with strong international research and industry experience. It is dedicated to developing innovative POCT technology platforms under the philosophy of "Faster, Better, and More Accessible". The company drives innovation through R&D centers in Guangzhou, Xiamen, and overseas. Using its proprietary dry light-excited chemiluminescence POCT platform, it has developed leading product series and managed major national research projects. The company has published over 20 SCI papers, holds 70 patents, has obtained more than 60 EU CE certifications, and 12 FDA approvals in the United States. Currently, several product lines are actively striving for NMPA certification. Its pipeline covers key areas including cardiovascular, inflammation, oncology, hormone, and infectious diseases, demonstrating end-to-end capabilities from R&D to global commercialization. The core team comprises graduates from top universities such as Texas A&M University, Xiamen University, Sanford-Burnham Medical Research Institute, and Sun Yat-sen University, possessing multidisciplinary expertise in biomedicine, engineering, and law. The co-founders have extensive experience from leading IVD companies, having previously guided teams to achieve annual revenues exceeding several hundred million yuan and secure over 200 product certifications worldwide. Since its establishment, Xenta Biomedical Science Co., Ltd has raised tens of millions in funding and obtained ISO 13485 certification, supporting its global expansion.
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Igenesis(Shanghai)Co.Ltd. · China
This diagnostic kit uses real-time multiple fluorescent PCR technology combined with an Automated Fully Enclosed qPCR Instrument. It is used for in vitro qualitative detection of high-risk HPV16, HPV18, and 16 other high-risk types (HPV26, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV53, HPV56, HPV58, HPV68, HPV59, HPV66, HPV73, and HPV82) in cervical exfoliated cells or reproductive tract secretions. Test results assist in HPV auxiliary diagnosis.
GUANGZHOU BIOTRON TECHNOLOGY CO., LTD. · China
HPV 15 genotype detection kit using fluorescence PCR melting curve analysis for identifying human papillomavirus types in clinical specimens. Enables rapid, simultaneous detection and differentiation of multiple HPV genotypes relevant to cervical cancer screening and risk stratification.
Yaneng BIOscience (Shenzhen) Co.,Ltd. · China
PCR-based human papillomavirus detection assay capable of identifying 23 HPV genotypes including 18 high-risk and 5 low-risk variants for cervical cancer screening and auxiliary diagnosis.
Yaneng BIOscience (Shenzhen) Co.,Ltd. · China
Comprehensive HPV genotyping kit detecting 23 distinct human papillomavirus types including 18 high-risk and 5 low-risk strains. Enables accurate HPV infection characterization for clinical management.
ACON Laboratories, Inc. · United States
A nucleic acid-based PCR test kit for genotyping of human papillomavirus. Provides comprehensive identification of HPV strains for clinical assessment.
Hangzhou DALTON BioSciences, Ltd. · China
A diagnostic test kit detecting 18 types of human papillomavirus including 14 high-risk types recognized by WHO as causative agents of cervical cancer and 4 medium-risk types associated with cervical cancer, using hybrid capture-chemiluminescence method.
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · China
This kit is suitable for in vitro qualitative detection of 17 types of human papillomavirus (HPV 6, 11, 16, 18, 31, 33, 35, 39, 44, 45, 51, 52, 56, 58, 59, 66, 68) specific nucleic acid fragments in urine samples, female cervical swab samples, and female vaginal swab samples, as well as HPV 16/18/6/11/44 typing detection.
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · China
A nucleic acid detection kit designed to identify 14 types of high-risk human papillomavirus (HPV) with specific genotyping for HPV types 16 and 18. This test kit enables comprehensive HPV screening and risk stratification for cervical cancer prevention. The kit provides detailed genotyping information for clinical management and patient counseling.
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · China
This kit is suitable for in vitro qualitative detection of 28 types of human papillomavirus (HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 66, 68, 73, 81, 82, 83) nucleic acids in clinical urine samples, female cervical swab samples, and female vaginal swab samples, as well as HPV 16/18/45 typing detection, while providing aid in the diagnosis and treatment of HPV infection.
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · China
This kit is suitable for in vitro qualitative detection of 18 types of human papillomavirus (HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) specific nucleic acid fragments in human urine samples, female cervical swab samples, female vaginal swab samples, and HPV 16/18 typing.
Igenesis(Shanghai)Co.Ltd. · China
A fully enclosed diagnostic kit with preloaded reagents for 6-plex detection of HPV types (HPV16, HPV18, and others) using cervical exfoliated cells and genital secretion samples. The kit employs magnetic beads extraction, purification, and qPCR method with results available within 2 hours and internal control monitoring throughout the process. It requires no freezer storage or transportation.
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · China
In vitro qualitative detection kit for 18 types of high-risk HPV using fluorescence PCR technology. Suitable for urine, cervical swab, and vaginal swab samples with HPV 16/18 typing capability. CE and TFDA approved for clinical diagnostic use.
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