Test, Phencyclidine (pcp), Over The Counter
Device Code: 6292
Product Code(s):
NGM Definition: The Phencyclidine Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Phencyclidine In Human Urine.
Device Classification Information
| Device Type ID | 6292 |
| Device Name | Test, Phencyclidine (pcp), Over The Counter |
| Physical State | In Vitro Diagnostic Device. |
| Technical Method | Urine Sample Assay. |
| Target Area | Urine. |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | NGM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6292 |
| Device | Test, Phencyclidine (pcp), Over The Counter |
| Product Code | NGM |
TPLC Last Update: 2019-04-02 21:19:57