Test, Methadone, Over The Counter
The Test, Methadone, Over The Counter is an in vitro diagnostic test for the qualitative analysis of methadone in human urine, available for over-the-counter use without a prescription, used in drug abuse monitoring and compliance testing. It is classified as FDA Class 2 under 21 CFR 862.3620 in the Clinical Toxicology specialty, requiring 510(k) premarket notification, and is eligible for third-party review. Product code PTG; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PTG
- Device Class
- FDA class 2
- Regulation Number
- 862.3620
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine.
FEI Numbers
This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.