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QZHClass III

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Unknown
FDA source (opens on fda.gov)

QZH is the FDA product code for Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit, a class III device type. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QZH
Device name
Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
FDA 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 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
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code