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.
- High-Volume Production Capacity: 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.
Let's Build Your Diagnostic Brand
Tell us your product, market and volume. Our team will respond within 24 hours.