QMS Vancomycin Immunoassay

GUDID 00884883012837

Microgenics Corporation

Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Primary Device ID00884883012837
NIH Device Record Keybf872922-c8b1-46fb-b6d5-f07f51f90030
Commercial Distribution StatusIn Commercial Distribution
Brand NameQMS Vancomycin Immunoassay
Version Model Number10017224
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
GS100884883012837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LEHRadioimmunoassay, Vancomycin

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 Date2016-09-22

On-Brand Devices [QMS Vancomycin Immunoassay]

0088488301283710017224
008848830112430373597
008848830111820373589

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