PTG — Test, Methadone, Over The Counter Class II
FDA product code PTG covers "Test, Methadone, Over The Counter", a Class II medical device regulated under 21 CFR 862.3620. Submissions are reviewed by the Clinical Toxicology panel.
Classification Details
- Product Code
- PTG
- Device Class
- Class II
- Regulation Number
- 862.3620
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine.