BIOSYSTEMS S.A.

BIOSYSTEMS S.A. specializes in diagnostic controls and reagents used in laboratory testing. Their products include standards like beta2-microglobulin and fecal occult blood (FOB) controls, antibody-specific controls such as anti-Jo1 and anti-tTG IgG, and solutions for sample preparation like alkaline washing solutions. They also produce reaction rotors for automated systems and reagents like transferrin, haptoglobin, and copper-based analytical tools. These are designed for clinical, veterinary, food & beverage, and environmental analysis.

BIOSYSTEMS S.A. is based in Spain (ES), which places its devices under EU regulatory oversight. Since some of its products are In Vitro Diagnostic (IVD) devices, they are registered in the EU via the eudamed database. Additionally, certain devices are listed in the FDA’s 510(k) pathway in the United States, demonstrating compliance with both regional regulatory requirements. The company’s location ensures alignment with EU IVD regulations while also enabling market access in the US through FDA clearance processes.

BIOSYSTEMS S.A.’s devices appear in eudamed (the EU’s official IVD registry) due to their classification as In Vitro Diagnostics under EU regulations. Some of their products are also listed in the FDA’s 510(k) database because they fall under US medical device regulations, requiring pre-market notification for market authorization. These registries ensure transparency and compliance with respective regional requirements for diagnostic and laboratory-use devices.

BIOSYSTEMS S.A.’s products are classified as Class A (low-risk) or Class II medical devices, depending on their intended use and potential risk. Some fall under the broader IVD General category, which includes diagnostic reagents and controls used in routine laboratory testing. Classification determines regulatory pathways—Class A devices typically require less stringent scrutiny, while Class II may involve additional safety and performance evaluations to ensure reliability in clinical, veterinary, or environmental applications.