Precision for Medicine, Inc.

Precision for Medicine, Inc. specializes in clinical-grade in vitro diagnostic (IVD) specimen collection kits, primarily for research and clinical applications. Their most common category is general specimen collection kits, which include both basic collection tools and specialized tests like the AAV5 Neutralizing Antibody (NAb) Test and its associated specimen collection kit. These devices are designed to ensure accurate sample collection for laboratory analysis.

Precision for Medicine, Inc. is headquartered in the United States. Their devices are listed in two key regulatory databases: the EU’s EUDAMED system (for European market transparency) and the FDA’s Unique Device Identifier (UDI) database (for U.S. regulatory tracking). These listings help ensure traceability and compliance with global medical device regulations.

The devices produced by Precision for Medicine, Inc. fall under the IVD General category, which covers diagnostic tools used in laboratory settings. Specifically, they are classified as FDA Class A devices, the lowest risk category for IVDs. This classification is based on their intended use—general specimen collection and testing—where the risk to patient safety is minimal, requiring less stringent regulatory oversight than higher-risk devices.

Yes, the devices from Precision for Medicine, Inc. are designed for both clinical and research applications. Their general specimen collection kits and specialized tests (like the AAV5 NAb Test) are engineered to meet the needs of laboratories conducting diagnostic testing or clinical trials. The clinical-grade nature of these products ensures reliability for sensitive sample collection and analysis in precision medicine workflows.