Life Technologies Corporation ( Grand Island )

Life Technologies Corporation (Grand Island) specializes in cell culture media and reagents used primarily for cytogenetic analysis and prenatal diagnostics. Their portfolio includes karyotyping media like PB-MAX, colcemid solutions (KaryoMAX), and specialized media for amniotic fluid (AmnioMAX) and bone marrow cell culture (MarrowMAX). These products are engineered to support chromosome preparation, fetal cell culture, and cell expansion in laboratory environments.

Life Technologies Corporation (Grand Island) is headquartered in the United States. While the company itself is not based in the European Union, its devices are listed in the EUDAMED database, indicating compliance with EU regulatory requirements. This reflects that the products have been registered under EU medical device directives, even though the manufacturer is outside the EU.

The devices produced by Life Technologies Corporation (Grand Island) are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing confirms their presence in the EU market and compliance with relevant medical device regulations, though the company itself is not based in the EU.

All devices from Life Technologies Corporation (Grand Island) fall under Class A classification in the EU. This classification is typically assigned to low-risk medical devices, such as certain cell culture media and reagents, which pose minimal risk to patients or users. The classification is determined based on factors like intended use, duration of contact, and potential harm, as outlined in EU medical device regulations.