QDR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Plazomicin Test System, Immunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3460
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA 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 infection.
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| Record | Firm | Date |
|---|---|---|
| QMS Plazomicin Immunoassay (DEN180030) | Microgenics Corporation | 2018-11-19 |
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Every clearance here is in the API, with alerts when new ones post.