Good News to Share! SEKBIO Achieves International ISO 13485 Quality Management System Certification

We are proud to announce that, after continuous effort and rigorous scrutiny, our company has successfully obtained ISO 13485 certification.


ISO 13485: A Commitment to Medical Quality and Safety

ISO 13485 ensures a commitment to medical quality and safety. This certification demonstrates our unwavering commitment to excellence in the entire process, from design and production to service. Through strict internal processes and world-class standards, we are firmly dedicated to providing the safest and most reliable products to patients and healthcare professionals.

Team Superpowers, Thumbs Up!

Behind this certification is the teamwork, expertise, and relentless pursuit of excellence by everyone. Your dedication to quality management and continuous improvement has earned us this honor!

The Future, Here We Come!

Obtaining ISO 13485 certification is not just a milestone for SEKBIO, but also a fresh beginning. We will continue to strive for higher quality standards, optimize our processes, and bring more surprises and better products to everyone! Stay tuned for more exciting developments!

Shenzhen SEKBIO is a technology research and development company specializing in the development of immunoreagents and CDMO services. With a mission to make diagnostics more accurate and a spirit of persistence and dedication, we are committed to developing more precise IVD diagnostic products.

Key Domestic Products and Services:

1) One-stop CDMO service of immunoassay, from concept to production

2) Chemiluminescence bulk reagents, ready to use reagents

3) Immunofluorescence strip plates, ready to use reagents

We offer free sample evaluations for chemiluminescence reagents. For those interested in our products, please contact us at:

ATTN: Faye Wand(Sales Manager)


Offical website: