StatLab Activates New U.S. Manufacturing Capabilities

StatLab Medical Products (StatLab) has launched new U.S.-based manufacturing capabilities, advancing its multi-year “in-region, for-region” strategy to ensure reliable, scalable production of critical reagents for pathology labs nationwide. The latest milestone—insourcing injection-molded prefill containers—further strengthens StatLab’s position as a main U.S. manufacturer of formalin prefills, producing nearly 100 million units annually, while increasing supply chain reliability for labs amid ongoing global uncertainty.

StatLab has long manufactured StatClick formalin prefills, but by becoming the first in the industry to vertically integrate container and lid production in-house, it is increasing control and reducing supply chain risk for this essential product, used daily in U.S. operating rooms and laboratories. In addition to bringing injection molding for prefill containers in-house, StatLab has also begun blow molding gallon bottles. Production capacity for cassettes continues to grow as well, with new injection molding cells added at its Arlington, Texas, facility to meet strong U.S. demand.

“At StatLab, it is in our DNA to invest ahead of the need,” StatLab CEO Sung-Dae Hong said. “As one of the market leaders for essential pathology consumables, insourcing key containers for the products we make, including gallon bottles and prefills, empowers us to control quality and protect our customers against external market forces.”

In another proactive move to support customers through challenging market conditions, StatLab plans to currently absorb any tariff-related fees associated with products manufactured in its European facilities when selling directly to U.S. laboratories. These products include PiSmart cassette and slide printers, KT microscope slides, and KT coverglass. By leveraging its U.S. and European manufacturing capabilities, StatLab can offer consumables for the full pathology workflow protected from tariff impact, empowering domestic customers to focus more on patient care.

“Delivering stability for our customers, especially in times of volatility, is part of the trust we build every day,” Hong continued. “We recognize the importance of predictable pricing and reliable access to the essential supplies labs need for accurate diagnoses.”

StatLab Medical Products has helped anatomic pathology laboratories provide the best possible patient care since 1976. Today, with the strength of its united brands and global locations, the company offers a line of self-manufactured consumables and pathology equipment, developed and produced across nine manufacturing sites in the United States, United Kingdom, and Europe. Its global operational footprint— powered by more than 750 mission-driven colleagues—enables an “in-region, for-region” manufacturing strategy, delivering a resilient, dependable supply chain and high-quality solutions.