Katsura Biological Corp.
The OEM Partner of Your Choice
ODM partners focusing on
biotechnology products
Katsura Biological Corp.
We position ourselves as a professional technical partner specializing in biotechnology ODM and medical device ODM, deeply involved in molecular diagnostics development and IVD system development. We assist brand clients in creating a complete system that is mass-producible, marketable, and regulatory compliant. From biological reagent development and diagnostic instrument integration to clinical diagnostic system construction, we integrate Reagent, Instrument, and Control System with a system-level design mindset to build a technology platform with scalability and long-term product strategy value, rather than just manufacturing a single product.
Supporting high-barrier molecular diagnostic products with engineering and regulatory capabilities
In the development of molecular diagnostics and in vitro diagnostics (IVD) products, we incorporate detection performance optimization (Sensitivity/Specificity/LoD/LoQ), contamination control, risk management, and batch consistency design from the early design stages to ensure reagent stability and system reliability. The development process follows the ISO 13485 quality management system, design control, and risk management framework, and supports FDA, IVDR, and TFDA regulatory strategies and submission planning, assisting products in successfully completing clinical validation and market access, and accelerating product commercialization.
Our Products ＆ Services
Products
Our devices for automated nucleic acid extraction and detection are flexible and efficient systems for a wide range of applications in Clinical Diagnostics & Research. The contamination-free magnetic rod technology of our extraction instruments gives you peace of mind for your sample extraction, while our portable and benchtop PCR solutions provides maximum flexibility for your downstream applications.
Services
Your OEM partner of choice, providing unique and reliable Laboratory Solutions for Clinical Diagnostic and Research Applications. We are a one stop shop, and we cover the complete spectrum of the product lifecycle from concept to design through manufacturing and after-market services.
