PROGENIKA BIOPHARMA, SA

Progenika Biopharma, SA specializes in in vitro diagnostic (IVD) tests focused on genetic analysis. Their devices include kits and controls for detecting alpha-1-antitrypsin deficiency using nucleic acid techniques (NAT), as well as IVD products for multiple blood group genotyping. These tests help identify specific genetic markers related to these conditions, supporting clinical decision-making.

Progenika Biopharma, SA is based in the United States. Since their devices are in vitro diagnostics, they must comply with U.S. regulatory requirements, including those set by the FDA. These requirements ensure the safety, performance, and accuracy of their genetic testing products before they enter the market.

Progenika Biopharma, SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their IVD products, including those used for alpha-1-antitrypsin deficiency testing and blood group genotyping, ensuring transparency and traceability in the medical device supply chain.

The FDA classifies Progenika Biopharma, SA’s devices under Class II and Class III categories. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require pre-market approval due to their critical role in patient health, such as certain genetic testing kits.