FDA Product Code NTI: Drug Metabolizing Enzyme Genotyping Systems
Intended To Identify The Presence Or Absence Of Human Genotypic Markers Encoding Drug Metaboizing Enzymes Using Dna Originating From Clinical Samples. This Type Of Assay Can Be Used As An Aid Determining Treatment Choice And Individualizing Treatment Dose For Therapeutics That Are Metabolized Primarily By The Specific Enzyme Tested By The System.
Leading manufacturers include Luminex Molecular Diagnostics, Inc..
List of Drug Metabolizing Enzyme Genotyping Systems devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Drug Metabolizing Enzyme Genotyping Systems devices (product code NTI). 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 Toxicology FDA review panel. Browse all Toxicology devices →