Test, Methadone, Employment And Insurance Testing, Exempt
Device Code: 6266
Product Code(s):
PVE Definition: Test, Methadone, Employment And Insurance Testing, Exempt FDA Has Exempted These Devices From The Premarket Notification Requirement By Publishing In The Federal Register Of July 11, 2017 (82 FR 31976) Available At Https://www.federalregister.gov/doc
Device Classification Information
| Device Type ID | 6266 |
| Device Name | Test, Methadone, Employment And Insurance Testing, Exempt |
| Physical State | Immunoassay |
| Technical Method | The Methadone Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Methadone In Human Specimens. The Test Is Intended For Employment And Insurance Testing Use As The First Step In A Two Step Process To Provide Information Concerning Th |
| Target Area | In Vitro Specimen |
| Regulation Description | Methadone Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.3620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PVE |
| 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 | 6266 |
| Device | Test, Methadone, Employment And Insurance Testing, Exempt |
| Product Code | PVE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Methadone Test System. |
| CFR Regulation Number | 862.3620 [🔎] |
TPLC Last Update: 2019-04-02 21:19:36