Plazomicin Test System, Immunoassay

QDR · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3460

Classification

FDA Product Code: QDR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3460
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown