Product code NTI

Device name

Drug Metabolizing Enzyme Genotyping Systems

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3360

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

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.

Source

FDA openFDA device classification dataset