Recently, Pilot Gene Technology (Hangzhou) Co., Ltd. has been granted an additional European in vitro diagnostic certification. With this approval, the entire product line of Pilot Gene's bloodstream infection series has obtained full certification, marking steady progress in the company's internationalization strategy, as well as continuous expansion of its overseas product layout and accelerated overseas market deployment.
CE Certificate Covered Product:AP10
As a leading enterprise in China's digital PCR industry, Pilot Gene upholds the mission of "Advancing Genetic Technology, Safeguarding Life and Health". Integrating R&D, manufacturing and sales, the company has developed a proprietary, industry-leading multi-color fluorescence channel digital PCR platform. Based on this platform, Pilot Gene has successively launched detection kits for multiple research and application areas, including infectious diseases, oncology, and reproductive genetics, while actively promoting the registration and certification of these kits to drive the leapfrog development of life sciences and clinical diagnostics.
Since obtaining its first CE mark in 2022, Pilot Gene has been granted more than 20 certificates in total, covering a full-cycle, all-round, complete product portfolio including nucleic acid sample preparation systems, digital PCR detection platforms, detection reagents and related consumables. This has laid a solid foundation for Pilot Gene to deepen its global market layout, expand international markets and serve customers worldwide.
CE-Certified Digital PCR Platforms
- Automated Nucleic Acid Detection Reaction Setup System AP10
- Automated Droplet Digital PCR System AD Series
- Digital PCR Workstation DW3200
- Compact Digital PCR Integrated System Pilot1200
Digital PCR Detection Reagents (All CE Certified)
- Kit for Detection of 20 Pathogenic Microorganisms and Drug Resistance Genes Associated with Bloodstream Infections
- Invasive Fungi Nucleic Acid Detection Kit
- Human Herpesviruses (Types 1–5) Multiplex Detection Kit
- Combined Detection Kit for Mycobacterium Tuberculosis / Non-Tuberculous Mycobacteria Nucleic Acids
