Explore our flagship solutions built for high-throughput laboratory automation and precise genomic execution.
Founded in 2017, Shenzhen BioX Medical Co., Ltd. has rapidly grown to become a premier designer and manufacturer of precision molecular diagnostic platforms and genetic screening tools. Headquartered in Shenzhen, China, our company capitalizes on an ecosystem of biotech innovation and medical engineering excellence to export industry-leading solutions globally.
Our expansive manufacturing footprint spans over 9,000 square meters, utilizing cleanrooms, automated calibration cells, and specialized quality inspection modules. With a dedicated team of more than 200 industry professionals, we provide end-to-end OEM and ODM support for clinical laboratories, research organizations, public health clinics, and global diagnostic product companies.
Modern genomic sequencing relies heavily on the stability and purity of the primary extraction. By utilizing advanced magnetic bead separation chemistry, BioX Medical's instrumentation platforms ensure optimized nucleic acid yield with zero cross-contamination. Whether managing low-concentration oncology markers or fast-acting pathogen screening, our equipment delivers diagnostic integrity where it matters most.
From single-gene sequencing to population-scale genomics, we optimize the entire workflow.
High-fidelity DNA/RNA purification engines directly feed clinical workflows, supporting cancer screening panels, hereditary genetic testing, and non-invasive prenatal tests (NIPT).
Rapid extraction instruments and high-throughput real-time PCR platforms enable immediate profiling of viral and bacterial epidemics in diagnostic setups.
Custom fluidic architectures and integration platforms designed for synthetic biology companies, agricultural genetic modification labs, and research biobanks.
Our engineering strength is verified by continuous investments in molecular R&D.
Ensuring compliance with major international standards to streamline import processes for global distributors.
Shenzhen BioX Medical Co., Ltd. operates under strict compliance with the ISO 13485:2016 medical device quality management standard. This ensures that every unit we produce—from microfluidic extraction systems to advanced qPCR thermal cyclers—undergoes exhaustive structural validation.
Our manufacturing line features state-of-the-art class 100,000 cleanrooms and high-precision machinery calibration systems, mitigating contamination risks for hyper-sensitive genetic assays.
We support our partners by facilitating localized regulatory approvals. Our molecular diagnostics devices come equipped with CE-IVD markings, enabling direct distribution within the European Economic Area.
We also supply complete documentation files, validation reports, and stability studies to assist in obtaining FDA 510(k), NMPA, or Health Canada approvals.
Integrating molecular diagnostics with macro environmental water systems and manufacturing mechanical automation.
Molecular assays and next-generation sequencing libraries require ultra-pure water. By offering high-efficiency Ultrafiltration (UF) systems, we secure purification baselines for reagent production lines.
Instrument mechanical stability relies on industrial backing. We supply customized mechanical servo assemblies and roof mounting configurations for facility energy control blocks.
Advanced genetic laboratories demand cryo-preservation options. Our nitrogen liquefiers offer rapid cooling parameters for sensitive long-read sequencing biobanking samples.
As the genomics industry shifts from traditional NGS panels toward spatial transcriptomics and long-read single-molecule sequencing, BioX Medical is steering its manufacturing protocols toward higher automation. We are actively developing microfluidic cartridges that integrate extraction, amplification, and library preparation into a single desktop-sized platform.
By investing in machine learning algorithms for real-time PCR Ct curve calibration, we strive to elevate the analytical accuracy of clinical diagnostics to 99.9%. Furthermore, our partnership network is expanding to deliver complete automated pipelines to clinical hubs in the APAC, Latin American, and European regions.
Technical answers from our engineering and regulatory affairs department.
A: We offer dynamic capacity scales. Our THR-BNP32 handles up to 32 samples per batch, whereas the high-throughput THR-BNP96 system runs up to 96 samples simultaneously. Both units utilize magnetic bead separation protocols with customizable mixing frequencies and temperature settings.
A: We provide complete technical files (TF), quality management documentation (ISO 13485), verification and validation test reports, and compliance statements for CE-IVD and other international certifications. We also grant access to factory performance metrics to expedite local registration processes.
A: Yes. While we optimize our platforms to run seamlessly with our dedicated purification kits, the software allows full customization of magnetic rod patterns, incubation periods, temperature ranges, and purification programs, allowing use of third-party magnetic bead reagents.
A: Standard OEM modifications (such as branding, custom UI interfaces, and casing colorations) require approximately 4 to 8 weeks. Comprehensive ODM builds, involving custom microfluidic channel redesign or integration of unique mechanical subsystems, take roughly 6 to 9 months, including rigorous quality testing.
A: Genetic testing procedures, gel document preparation, and automated ELISA processes are highly sensitive to mineral contaminants, DNase, and RNase. Our industrial-grade ultrafiltration (UF) systems generate high-quality reagent water, preventing trace contamination from skewing PCR or sequencing outcomes.
A: Our qPCR systems employ advanced thermoelectric cooling modules (Peltier elements) combined with automated optoelectronic sensors. They feature internal voltage fluctuation safety overrides, thermal overheating sensors, and vibration-dampening structures to ensure assay precision over millions of amplification runs.
A glimpse into Shenzhen BioX Medical's state-of-the-art facility, calibration labs, and shipping depots.
From mechanical infrastructure support to critical water treatment and diagnostic instruments.
BioX Medical