Definition: A Plazomicin Test System Is A Device Intended To Measure Plazomicin In Human Specimens. Measurements Obtained By This Device Are Used In Monitoring Levels Of Plazomicin To Ensure Appropriate Therapy In Patients With Complicated Urinary Tract Infectio
| Device Type ID | 6276 |
| Device Name | Plazomicin Test System, Immunoassay |
| Physical State | In Vitro Diagnostic Test In Patients With Complicated Urinary Tract Infection |
| Technical Method | Quantitative Immunoassay |
| Target Area | Human Plasma Specimens |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3460 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6276 |
| Device | Plazomicin Test System, Immunoassay |
| Product Code | QDR |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.3460 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
THERMO FISHER SCIENTIFIC | ||
GRANTED | 1 | |