Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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US Regulatory Classifications
Device Characteristics
No
No
No
Not Eligible
Definition
A qualitative in vitro molecular test that detects select variants in genomic DNA isolated from human specimens. Results of the test provide users with a genetic risk assessment of developing Opioid Use Disorder (OUD) and are intended to aid users with informed decision-making regarding the use of oral opioids for acute pain relief. The test may not include all variants associated with a risk of developing OUD and is not intended to describe a personยs overall risk of developing OUD. Results from the system are intended to be used in combination with clinical information and should not be the sole determinant in diagnosing, counseling, or making prescribing decisions
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