R&D-BASED IVD MANUFACTURER · SINCE 2012
Your One-Stop IVD Rapid Test Manufacturer
One R&D-based OEM/ODM partner for your full rapid-test range, trusted by 500+ distributors across 100+ countries.
Your One-Stop IVD Manufacturing Partner
One-Stop IVD Solutions
We handle the full in vitro diagnostic supply chain under one roof: from R&D and raw materials to manufacturing, packaging and export documentation.
Learn moreFlexible OEM & ODM
Custom formats, private-label packaging and tailored specifications. We serve 500+ global distributors with custom branded diagnostic lines.
Learn moreDocumentation & Technical Support
Regulatory and CE documentation support to help you register and launch faster in your market.
Learn moreComprehensive IVD Rapid Test Portfolio
A broad range of rapid diagnostic tests across eight categories, engineered for accuracy, stability and ease of use. All products are ready for OEM/ODM customization.
Drugs of Abuse (DOA)
Multi-panel urine drug screening tests for workplace and clinical use.
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Manufacturing Engineered for Quality
An R&D-driven IVD rapid test manufacturer built for reliable, high-volume production.
- ISO 13485 & CE Certified: World-class IVD quality management, with CE-marked rapid test products.
- NMPA (CFDA)-Approved IVD Manufacturer: Licensed to manufacture and trade in vitro diagnostic reagents in China.
- In-House R&D Laboratories: Continuous rapid test development and product innovation.
- 3,000 m² Facility with ISO Class 8 Cleanroom (100,000-grade): Includes an ISO Class 7 microbiology testing room (10,000-grade) and dedicated QC laboratories.
- 300 Million Units Annual Production Capacity: High-volume rapid test manufacturing built for large export orders.
- One-Stop OEM/ODM Manufacturing Since 2012: 14+ years of rapid test manufacturing for 500+ global distributors across 100+ countries.
Certified for Global Markets
ISO 13485
Quality Management System
CE
European Conformity
NMPA (CFDA)
China Manufacturing Approval
Operating under an ISO 13485 quality management system, with CE-marked products and NMPA (CFDA) manufacturing approval.
GLOBAL PRESENCE
Meet PRISES at the World's Leading Diagnostic Trade Shows
We exhibit at 5+ international medical and diagnostic trade shows every year, connecting with distributors and partners across the globe.
WHAT OUR CLIENTS SAY
Trusted by Distributors Worldwide
Hundreds of 5-star reviews from distributors and buyers worldwide.
Let's Build Your Diagnostic Brand
Tell us your product, market and volume. Our team will respond within 24 hours.