Test, Tricyclic Antidepressants, Over The Counter
The Test, Tricyclic Antidepressants, Over The Counter is an in vitro diagnostic test intended to measure tricyclic antidepressant drugs in serum or urine, used for over-the-counter detection of tricyclic antidepressant presence for purposes such as monitoring or preliminary screening. It is classified as a Class 2 device under regulation 862.3910, requiring 510(k) premarket notification and eligible for third-party review, falling within the Clinical Toxicology (TX) medical specialty. The product code is QAW. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QAW
- Device Class
- FDA class 2
- Regulation Number
- 862.3910
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
FEI Numbers
This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.