Prothrombin time (PT) IVD, kit, rapid clotting, clinical

This category includes in vitro diagnostic kits designed to measure prothrombin time (PT) from clinical specimens using a rapid clotting method. These kits contain reagents and associated materials that allow for qualitative or semi-quantitative PT determination, with or without conversion to the international normalized ratio (INR), and are intended for use in laboratory or point-of-care settings to assess blood coagulation status quickly.

Devices in this category are regulated as in vitro diagnostic medical devices and are supplied as complete kits for professional use only. They are not intended for self-testing and rely on a clotting-based methodology to deliver results in a shorter timeframe than conventional laboratory PT tests.