Device typeOpioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine the risk of developing opioid use disorder (OUD) based on multiple disease-associated genotypes, using a nucleic acid technique (NAT). These genotypes may include, but are not limited to, variants of the methylenetetrahydrofolate reductase (MTHFR), mu-opioid receptor, galanin (GAL) and ABCB1 genes.
FDA categoryOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
Device ID10850009370249
Catalog number03-6560-01
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information