Industrial Source

Industrial Source specializes in producing gas mixtures for in vitro diagnostic (IVD) applications. Their primary products include blood gas analyser mixtures—such as clinical, anaerobic, and calibration formulations—for point-of-care testing. They also supply mixtures for carbon monoxide breath analysis and lung diffusion testing, which simulate physiological and pathological gas conditions to ensure accurate analyte measurement in diagnostic devices.

Industrial Source is based in the United States. Their devices are designed and intended for use within the U.S. regulatory environment, adhering to applicable medical device standards and requirements.

Industrial Source’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class I medical devices, ensuring transparency and traceability in compliance with U.S. medical device regulations.

Industrial Source’s gas mixtures are classified as Class I devices. This classification is determined based on their intended use—simulating gas conditions for diagnostic testing—and their low-risk profile, as defined by regulatory authorities. Class I devices typically undergo general controls but may not require additional premarket approvals.