Gabapentin Assay
Device Code: 6253
Product Code(s):
OTF Definition: Test For The Quantitative Determination Of Gabapentin In Human Serum Or Plasma. Gabapentin Concentrations Can Be Used As An Aid In Management Of Patients Treated With Gabapentin.
Device Classification Information
| Device Type ID | 6253 |
| Device Name | Gabapentin Assay |
| Physical State | Liquid Reagents |
| Technical Method | Quantitative, Homogenous Enzyme Immunoassay |
| Target Area | In Vitro Diagnostic |
| Regulation Description | Diphenylhydantoin 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 | 862.3350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OTF |
| 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 | 6253 |
| Device | Gabapentin Assay |
| Product Code | OTF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diphenylhydantoin Test System. |
| CFR Regulation Number | 862.3350 [🔎] |
TPLC Last Update: 2019-04-02 21:19:25