Nanocomposix, LLC

Nanocomposix, LLC specializes in in vitro diagnostic (IVD) reagents. Their primary products include citrate staining reagents, polyethylene glycol (PEG) immunohaematology reagents, and pH-adjusted buffer solutions. These reagents are used in laboratory settings for tasks like blood compatibility testing and sample preparation, ensuring accurate diagnostic procedures.

Nanocomposix, LLC is based in the United States. Since it operates within the U.S., its IVD devices must comply with FDA regulations. The company’s products are designed to meet U.S. regulatory standards, which govern the safety, performance, and labeling of medical devices in the country.

Nanocomposix, LLC’s IVD devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes.

Nanocomposix, LLC’s IVD reagents fall under the FDA’s Class I device classification. This classification is assigned to devices with minimal risk to patients, such as certain reagents used in laboratory testing. Class I devices typically undergo less stringent regulatory scrutiny compared to higher-risk categories, reflecting their lower potential for harm.