FDA Product Code NPR: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
The Factor II G20210A mutation increases the risk of venous thromboembolism. FDA product code NPR covers in vitro diagnostic tests for the detection of Factor II G20210A mutations by genomic DNA PCR.
These molecular assays identify the prothrombin gene mutation associated with elevated plasma prothrombin levels and increased thrombotic risk, informing anticoagulation decisions in patients with VTE or family history of clotting disorders.
NPR devices are Class II medical devices, regulated under 21 CFR 864.7280 and reviewed by the FDA Pathology panel.
Leading manufacturers include Cepheid and Roche Molecular Systems, Inc..
List of Test, Factor Ii G20210a Mutations, Genomic Dna Pcr devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Test, Factor Ii G20210a Mutations, Genomic Dna Pcr devices (product code NPR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Hematology FDA review panel. Browse all Hematology devices →