Streck

Streck specializes in in vitro diagnostics (IVDs) primarily for hematology and blood collection. Their portfolio includes controls and calibrators for full blood count assays, reticulocyte counts, erythrocyte sedimentation rate (ESR), and glucose/hemoglobin measurements. They also produce evacuated blood collection tubes (with additives like sodium citrate and potassium EDTA) and specialized kits for viral extraction and blood sample preservation. These devices support laboratory testing and blood handling workflows.

Streck is headquartered in the United States. The regulatory classification of their devices varies by jurisdiction: in the EU, most are classified as Class A or Class B, while in the US, they fall under Class I or Class II. Classification depends on factors like risk level, intended use, and procedural involvement, not the company’s location.

Streck’s devices are listed in multiple regulatory databases to ensure transparency and traceability. They appear in the EU’s eudamed registry, the FDA’s 510(k) clearance database (for premarket notifications in the US), and the FDA’s Unique Device Identifier (UDI) system, which standardizes device identification for tracking and compliance purposes.

Streck’s devices are classified differently based on regional regulations. In the EU, most fall under Class A (low risk, e.g., some controls) or Class B (moderate risk, e.g., certain hematology assays). In the US, they are classified as Class I (low risk, e.g., evacuated tubes) or Class II (moderate risk, e.g., viral extraction kits). Classification depends on factors like procedural intervention, patient contact, and potential harm, not the device type alone.