RANDOX LABORATORIES LIMITED

Randox Laboratories Limited manufactures a range of laboratory consumables and controls for clinical diagnostics, including liquid chemistry controls, immunoassay controls, serology controls, and microbiome sample collection kits. Their products also cover wash buffers, acid wash solutions, and customizable controls for therapeutic drug monitoring and specific assays like BNP and ToRCH IgM testing. The company provides both standard and bespoke solutions for diagnostic laboratories, such as the Randox Discovery system and specialized reagents for immunoassays.

The company’s portfolio includes devices classified under EU Class A, B, and C, as well as FDA Class I and II, reflecting a mix of low-risk and moderate-risk medical devices. Their products are registered in the EU’s EUDAMED database and the FDA’s 510(k) premarket notification system, indicating compliance with European and US regulatory requirements. The manufacturer operates from the UK.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.