Katsura Biological Corp

Katsura Biological Corp specializes in molecular biology diagnostic reagents, including kits and solutions. These products are designed for laboratory use in genetic and biochemical testing, such as PCR-based assays, cloning, and DNA/RNA manipulation. Their focus is on supporting research and clinical diagnostics by providing tools for precise molecular analysis.

Katsura Biological Corp is based in Taiwan, specifically in New Taipei City (新北市). The company operates from this location while serving global markets with its diagnostic reagents and distribution services.

Katsura Biological Corp’s diagnostic reagents are listed in the EUDAMED database, which is the European Union’s medical device registry. This registration reflects their compliance with EU medical device regulations, though individual devices must still meet specific authorization requirements.

Katsura Biological Corp’s diagnostic reagents fall under EU Class A medical devices. This classification is typically assigned to low-risk devices, such as certain in vitro diagnostic (IVD) reagents, based on their intended use and potential risk to patients or users. Classification determines regulatory pathways, but it does not imply authorization—each device must still comply with applicable EU laws.

Yes, in addition to manufacturing its own diagnostic reagents, Katsura Biological Corp also serves as a distributor for third-party brands. Specifically, they act as an authorized representative for New England Biolabs (NEB) and AITbiotech, offering their products alongside their own molecular biology solutions.