QDR — Plazomicin Test System, Immunoassay Class II
FDA product code QDR covers "Plazomicin Test System, Immunoassay", a Class II medical device regulated under 21 CFR 862.3460. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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 |