Definition: Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.
| Device Type ID | 6273 |
| Device Name | Test, Tricyclic Antidepressants, Over The Counter |
| Physical State | The Device May Be Composed Of A Collection Apparatus And/or Detection Assay. |
| Technical Method | Urine Is Collected And Analyzed For The Presence Of Antidepressant Drugs. |
| Target Area | Urine |
| Regulation Description | Tricyclic Antidepressant Drugs Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |