QDR · Class II · 21 CFR 862.3460

FDA Product Code QDR: Plazomicin Test System, Immunoassay

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.

Leading manufacturers include Microgenics Corporation.

Total

Cleared

147d

Avg days

2018

Since

FDA 510(k) Cleared Plazomicin Test System, Immunoassay Devices (Product Code QDR)

1 devices

1–1 of 1

Not Cleared Nov 19, 2018

QMS Plazomicin Immunoassay

DEN180030

Microgenics Corporation

Toxicology · 147d

About Product Code QDR - Regulatory Context

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Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Nov 19, 2018

Product Code Info

Code	QDR
Device class	Class II
CFR	21 CFR 862.3460
Panel	Toxicology

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