Fluorescence PCR-based detection kit for Human Papillomavirus (HPV) identification in clinical specimens. Enables rapid, sensitive HPV genotyping for cervical cancer screening and risk stratification in diagnostic laboratories. 510(k) cleared device with fluorescence-based detection methodology.
Manufactured by
Houston, TX, United States
Healgen Scientific, a wholly owned subsidiary of Zhejiang Orient Gene Biotech Co.,Ltd, develops, manufactures and commercializes in-vitro diagnostic test systems worldwide. Our product portfolio spans multiple testing categories and analytes to meet various clinical and laboratory needs. Our testing platforms include rapid testing, molecular diagnostics, and multiplex flow cytometry. Since our inception in 2007, we have strived to develop devices that meet and exceed industry standards. The manufacturing process is supported by our interactive and highly-skilled Research and Development team, who are actively redefining the efficiency and design of our products. Our ambition is worldwide, and we currently provide products to customers in: USA, Europe, Middle-East, South Asia, Africa and Latin America for a total of 80+ countries. Our mission is to provide premier support to our distributors and partners. We have a flexible strategy on business cooperation, where we offer OEM options. Our success is supported by our professional personnel and good manufacturing practice. Healgen™ and DIAGNOSTAR™ are registered trademarks of Healgen Scientific LLC. These are produced and manufactured by Healgen Scientific LLC.
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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.
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Molecular diagnostic test for human papillomavirus detection using polymerase chain reaction technology. Enables nucleic acid-based identification of HPV pathogens for clinical screening applications.
Triplex International Biosciences(China) Co.,LTD. · China
A diagnostic test kit for the detection of human papillomavirus types 16 and 18 using PCR with fluorescence methodology. This kit is used to identify HPV infection status in clinical specimens.
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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.
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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.
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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.
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Advanced Molecular Diagnostics Ltd. · United Kingdom
Real-time PCR assay for high-risk HPV detection and screening. Supports cervical cancer prevention through HPV risk assessment.
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.
Genes 2Me Private Ltd · India
Real-time PCR assay for human papillomavirus detection and genotyping. Provides rapid, accurate HPV testing for cervical cancer screening applications.
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.
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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.
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