GENTC

GUDID 00884883007123

Microgenics Corporation

Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883007123
NIH Device Record Key1276897b-cae9-4e60-9cae-8fe08c0d3994
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENTC
Version Model Number08772525 190
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883007123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCDEnzyme Immunoassay, Gentamicin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-28
Device Publish Date2019-11-20

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