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Drug Metabolizing Enzyme Genotyping Systems

FDA product code NTI · 10 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3360
Review panel
TX
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2005-01-10 – 2023-03-21

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.

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