QDR — Plazomicin Test System, Immunoassay Class II
Classification Details
- Product Code
- QDR
- Device Class
- Class II
- Regulation Number
- 862.3460
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180030 | microgenics corporation | QMS Plazomicin Immunoassay | November 19, 2018 |