Biorex Labs LLC

Biorex Labs LLC specializes in in vitro diagnostic (IVD) products used in clinical settings. Their primary offerings include acetone test reagents and controls for intravenous diagnostics, as well as rapid colorimetric urine bilirubin test kits. These devices are designed for point-of-care or laboratory use to measure acetone and bilirubin levels in patient samples, helping with diagnostic assessments.

Biorex Labs LLC is headquartered in the United States. The company’s location aligns with U.S. regulatory requirements for the medical devices it develops and markets.

Biorex Labs LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures compliance with U.S. regulatory standards for Class I medical devices, which are subject to minimal oversight due to their low-risk classification.

Biorex Labs LLC’s devices fall under Class I classification in the U.S. regulatory framework. This classification applies to low-risk medical devices, including their acetone IVD reagents, controls, and urine bilirubin test kits, which require less stringent regulatory scrutiny compared to higher-risk categories.