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HUIANBIO Achieves Regulatory Milestone: Strep A Antigen Test Kit (Colloidal Gold) Gains NMPA Approval
September 27, 2025 | Shenzhen, China
Shenzhen HUIANBIO Technology Co., Ltd. is proud to announce the official approval of its Streptococcus A (Strep A) Antigen Test Kit (Colloidal Gold Method) by China's National Medical Products Administration (NMPA) (Approval Number: [To be supplemented]). This milestone enables global market supply of this critical diagnostic solution.
Product Highlights
✅ Technology: High-sensitivity colloidal gold immunochromatography for rapid detection of Group A Streptococcus antigens
✅ Clinical Application: Enables early screening and diagnosis of Strep A infections in medical institutions and point-of-care settings
✅ Certification: Complies with China's NMPA quality system standards and In Vitro Diagnostic Reagent Quality Management requirements
This approval reinforces HUIANBIO's commitment to delivering innovative diagnostic solutions for global infectious disease management. The test kit offers:
• Rapid Results: Detection within 15 minutes
• High Accuracy: Validated specificity and sensitivity in clinical trials
• User-Centric Design: Equipment-free operation for resource-limited settings
As a professional IVD manufacturer based in Shenzhen, HUIANBIO has established a comprehensive portfolio covering infectious disease testing, reproductive health, and chronic disease management. This clearance follows recent approvals of our Helicobacter Pylori and Gardnerella Vaginalis antigen test kits, demonstrating our robust R&D capabilities.
For international partnership inquiries, please contact:
📧info@huiantech.com
🌐http://www.huianbiotech.com
HUIANBIO – Advancing Global Health Through Diagnostic Innovation