510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QDRClass II

Plazomicin Test System, Immunoassay

21 CFR 862.3460 / Clinical Toxicology
FDA source (opens on fda.gov)

QDR is the FDA product code for Plazomicin Test System, Immunoassay, a class II device type, regulated under 21 CFR 862.3460. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
QDR
Device name
Plazomicin Test System, Immunoassay
FDA 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.
Regulation
21 CFR 862.3460
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
1

Clearances, product code QDR

By decision year
1 clearance under product code QDR with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QDR by decision year
YearClearances
20181

Applicants with the most clearances

Product code QDR
Applicants holding the most 510(k) clearances under product code QDR
ApplicantClearances
Microgenics Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code