DIASORIN IRELAND LIMITED

DIASORIN IRELAND LIMITED manufactures in vitro diagnostic (IVD) kits specifically designed for detecting Parvovirus B19 antibodies. These kits use enzyme immunoassay (EIA) technology to measure immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies, which help determine current or past infections. The devices are intended for laboratory use to assist in clinical diagnostics.

DIASORIN IRELAND LIMITED is based in the United States. Its devices fall under the classification of in vitro diagnostics, which are regulated by authorities like the FDA to ensure safety, performance, and proper use in laboratory settings. The company’s products are listed under the FDA’s Unique Device Identification (UDI) system, which helps track and manage medical devices in the US.

The devices manufactured by DIASORIN IRELAND LIMITED are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures that each device has a unique identifier, improving traceability and compliance tracking in the United States.

The devices from DIASORIN IRELAND LIMITED are classified as in vitro diagnostics (IVDs). This classification matters because IVDs are subject to specific regulatory oversight to ensure they perform accurately and safely in laboratory settings. Authorities like the FDA evaluate these devices to confirm they meet standards for detecting or diagnosing diseases, such as Parvovirus B19 infections, based on antibody presence.