FDA Product Code GJS: Test, Time, Prothrombin

Monitoring the coagulation cascade is critical in patients on anticoagulant therapy. FDA product code GJS covers prothrombin time tests.

The PT test measures the time it takes for plasma to clot via the extrinsic coagulation pathway, reflecting the activity of factors I, II, V, VII, and X. It is expressed as INR for warfarin monitoring and is used in the assessment of liver function and coagulopathies.

GJS devices are Class II medical devices, regulated under 21 CFR 864.7750 and reviewed by the FDA Hematology panel.

Leading manufacturers include Instrumentation Laboratory CO, Roche Diagnostics Corp. and Helena Laboratories.