List of Cleared and Approved Companion Diagnostic Devices (In Vivo and Imaging tools)
A companion diagnostic device can be an in vitro diagnostic (IVD) device or an imaging tool that provides information for the safe and effective use of a corresponding therapeutic product. The List of Cleared and Approved Companion Diagnostic Devices (In Vivo and Imaging tools) pulls information from the Drugs@FDA and Premarket Approval (PMA) databases. The List contains information on the therapeutic product, its generic and biosimilar equivalents, its New Drug Application (NDA) number, the corresponding diagnostic device name, its Premarket Approval (PMA) number, the device manufacturer, and its intended use or indications for use. The List is updated periodically.