CEDIA Tobramycin II Assay

GUDID 00884883005631

Microgenics Corporation

Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883005631
NIH Device Record Keya7d59bb3-eae0-41e7-8e9a-c159a0d157fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Tobramycin II Assay
Version Model Number100018
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883005631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFWFluorescence Polarization Immunoassay, Tobramycin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

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