FDA Product Code OVK: Cytokeratin Fragments 21-1 Eia Kit
The Cyfra 21-1 Eia Kit Is Intended For The Quantitative Determination Of Soluble Cytokeratin 19 Fragments In Human Serum. The Assay Is To Be Used As An Aid In Monitoring Disease Progression During The Course Of Disease And Treatment In Lung Cancer Patients. Serial Testing For Patient Cyfra 21-1 Assay Values Should Be Used In Conjunction With Other Clinical Methods Used For Monitoring Lung Cancer.
Leading manufacturers include Fujirebio Diagnostics,Inc..
List of Cytokeratin Fragments 21-1 Eia Kit devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Cytokeratin Fragments 21-1 Eia Kit devices (product code OVK). 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 →