Building a Global IVD Supply & Market Access Platform from China
π’ 1995 β
π Registered with the Beijing Administration for Industry and Commerce.
Recognized as a High-Tech Enterprise, laying the foundation for innovation in diagnostics.
π 1998 β
π Obtained the first NMPA (China Ministry of Health) registration certificate for a Human Chorionic Gonadotropin (HCG) diagnostic kit (Colloidal Gold method).
π¬ 1999 β
π Participated in Chinaβs National 863 Program, developing ELISA kits for Helicobacter pylori antibody detection.
π₯ 2001 β
π First in China to receive registration approval for Helicobacter pylori antibody ELISA kits.
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2005 β
π Achieved first GMP certification, establishing standardized manufacturing capabilities.
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2006β2015 β
π Continuous breakthroughs in infectious disease diagnostics, including:
- Cytomegalovirus (CMV) IgM
- Epstein-Barr Virus (EBV)
- TORCH panel (multiple formats)
- Hepatitis D virus
- EV71 virus
- Respiratory pathogens (multi-panel detection)
π Multiple national and provincial scientific awards, demonstrating strong R&D capabilities.
π 2016β2018 β
π Achieved ISO 13485 certification and advanced into:
- Chemiluminescence platforms
- Magnetic microparticle technologies
- Automated diagnostic solutions
π Expanded product portfolio covering comprehensive infectious disease diagnostics and prenatal screening.
π 2019 β
π Transition from manufacturing to global platform integration:
- Hongbang Technology (Qingdao) Co., Ltd. joined the ecosystem
- Launch of GAGN brand
- Initiated international distribution and market expansion strategy
π Marking the shift toward a global IVD supply and service platform
π‘ 2020 β
π Rapid response to global health challenges:
- Development of SARS-CoV-2 diagnostic solutions
- CE-certified COVID-19 Antigen Rapid Test
- Large-scale supply of virus sampling kits
π Strengthened capability in rapid product deployment and global supply chain response
π 2021β2022 β
π Expansion into advanced diagnostics and automation:
- Fully automated nucleic acid extraction systems
- Chemiluminescence analyzers
- Multi-product regulatory approvals across international markets
π Strengthened compliance, automation, and integrated solution capabilities
π 2023 β
π Market expansion into Central Asia (Turkmenistan):
- Partnerships with leading public and private healthcare institutions
- Launch of local registration and market access projects
- Direct supply of IVD equipment and reagents
π Establishing a localized service model combining supply + regulatory support
π 2024 β
π Major breakthrough in the Russian market:
- Won tender with one of the largest laboratory networks in Russia
- Secured long-term contracts for equipment, reagents, and service
π Strengthened position as a trusted IVD platform partner across CIS markets
π Today, ChinaIVD operates as an integrated platform offering:
- Global IVD product sourcing from China
- Regulatory registration & compliance support
- Local partnership development and tender support
π From factory to market β we deliver complete IVD solutions.