Test, Barbiturate, Over The Counter
Device Code: 6258
Product Code(s):
PTH Definition: The Barbiturate Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Barbiturates In Human Urine.
Device Classification Information
| Device Type ID | 6258 |
| Device Name | Test, Barbiturate, Over The Counter |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Immunoassay |
| Target Area | Urine |
| Regulation Description | Barbiturate 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 | 862.3150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6258 |
| Device | Test, Barbiturate, Over The Counter |
| Product Code | PTH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Barbiturate Test System. |
| CFR Regulation Number | 862.3150 [🔎] |
TPLC Last Update: 2019-04-02 21:19:29