QZH

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

产品代码

QZH

器械名称

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

管理类别

第 3 类（Class III）

FDA 专业组

Unknown

上市路径

需 PMA 上市前批准

FDA 分类定义

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 person’s 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

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。