ScheBo r. Biotech Aktiengesellschaft

ScheBo r. Biotech Aktiengesellschaft specializes in in vitro diagnostic (IVD) kits, specifically enzyme immunoassay (EIA) tests for measuring pancreatic elastase-1 (PE-1) levels. These tests help assess pancreatic function and are primarily used to diagnose conditions like chronic pancreatitis and cystic fibrosis-related pancreatic insufficiency.

The company operates from the United States, though its regulatory focus and device listings align with U.S. compliance frameworks like the FDA’s Unique Device Identifier (UDI) database.

ScheBo’s pancreatic elastase IVD kits are included in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and compliance with U.S. regulatory requirements for Class I devices.

ScheBo’s pancreatic elastase IVD kits fall under Class I medical device classification. This classification is typically assigned to low-risk devices where general controls are sufficient to ensure safety and performance, such as certain diagnostic tests.