FDA Product Code NIG: System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
An In Vitro Diagnostic Test For The Quantitative Measurement Of The Ca 19-9 Tumor Associated Antigen In Human Serum Or Plasma. The Test Is Intended As An Aid In The Management Of Patients With Confirmed Pancreatic Cancer And Serial Monitoring Of Their Response To Therapy And Disease Progression. The Test Should Only Be Used In Patients With Serum And Plasma Ca 19-9 Values Above The Cut-off At The Time Of Diagnosis And In Conjunction With Other Clinical Methods.
Leading manufacturers include Ortho-Clinical Diagnostics.
List of System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer devices (product code NIG). 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 Immunology FDA review panel. Browse all Immunology devices →