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U.S. Department of Health and Human Services

Product Classification

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Device plazomicin test system, immunoassay
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.
Physical State In vitro diagnostic test in patients with complicated urinary tract infection
Technical Method Quantitative immunoassay
Target Area Human plasma specimens
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeQDR
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3460
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons