CEDIA MultiDrug Optional Controls

GUDID 00884883004801

Microgenics Corporation

Multiple drugs of abuse IVD, control
Primary Device ID00884883004801
NIH Device Record Key49a8682e-e463-4673-9687-0b7f6846df8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA MultiDrug Optional Controls
Version Model Number100069
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100884883004801 [Primary]

FDA Product Code

DIFDrug Mixture Control Materials
DKBCalibrators, Drug Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-10
Device Publish Date2016-09-22

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