Overview
For IVD manufacturers and clinical customers, we provide integrated solutions for detection kits, covering product portfolio, quality control systems and compliance documentation to support market entry.
What We Provide
- Product portfolio: mature kits for pathogen detection and genotyping
- Quality control: internal controls, positive/negative references and result interpretation guidance
- Compliance: CE (IVDR), ISO 13485 and medical device filing support
- Labeling: multilingual instructions for use and declarations of conformity
Service Support
- Sample evaluation before formal cooperation
- Remote technical onboarding and experimental guidance
- Local market access support: compliance research assistance
For serious commercial enquiries, complete qualification documents issued by partner manufacturers are available on request.