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Industrial capabilities

Our automated, modular manufacturing enables us to bring products to market faster and more affordably. We produce 100,000 test kits per month at our our state-of-the-art facility, with capacity for 1 million per month. We use proprietary technology to develop consumables and control production of all hardware, software, and biologics.

Quality control

Real-time data collection and end-to-end product traceability are core values we employ in our connected QMS, ERP and shop-floor systems. With the strong foundation built by our quality, operational and regulatory teams, we are ISO:13485, MDSAP certified, with global product registrations across verticals in process.

Manufacturing facility worker

Highly-scalable manufacturing

Our design and manufacturing team focuses
on scalability at the start of the product creation process. We target 5-6 second process cycle
times and focus on traceability through digital shop floor control systems.

  • ISO13485:2016 and MDSAP Certified manufacturing facilities
  • Adapted processes and techniques from printed circuit board industry allows for reutilization of existing industry machinery.
  • Compact manufacturing foot-print while maintaining high volume production.
  • Highly automated workflows enable 100% part inspection at high yields.

Resource Center

Explore Fluxergy's information hub with webinars, product materials, how-to-videos, and more.

ISO 13485:2016
MDSAP
cGMP
CE IVD
"Fluxergy technology has a great potential to start a new era in the diagnostic field"

Dr. Lucjan Witzkowski, DVM, PhD

Warsaw University of Life Sciences