BIOCHROM LIMITED

Biochrom Limited specializes in in vitro diagnostic (IVD) devices focused on amino acid analysis. Their products include automated amino acid analysers, such as the Bio30+ Series, and reagent kits like the Ultra Ninhydrin-based solutions. These devices are designed for clinical and research applications requiring precise measurement of amino acids in physiological and high-performance testing contexts.

Biochrom Limited is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, including classification under the FDA’s device hierarchy. The company’s products fall under Class I medical devices, which typically require less stringent regulatory oversight than higher-risk classes, though compliance with FDA requirements remains essential for market authorization.

Biochrom Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for each authorised device, allowing healthcare providers, regulators, and other stakeholders to identify and verify the specific products under the company’s portfolio.

Biochrom Limited’s devices are classified as Class I medical devices by the FDA. This classification is based on their intended use—primarily as automated analysers and reagent kits for amino acid testing—which poses minimal risk to patients. Class I devices generally undergo less rigorous premarket review but must still meet FDA compliance standards for safety and performance.