Plazomicin Test System, Immunoassay
The Plazomicin Test System, Immunoassay is an in vitro diagnostic device intended to measure plazomicin levels in human specimens, with measurements used to monitor drug levels and ensure appropriate therapy in patients being treated for complicated urinary tract infection. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review, under regulation 862.3460 in the Clinical Toxicology specialty. The product code is QDR. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDR
- Device Class
- FDA class 2
- Regulation Number
- 862.3460
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN180030 | QMS Plazomicin Immunoassay | Nov 19, 2018 | Unknown | Microgenics Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.