DRI Negative Alcohol Calibrator

GUDID 00884883005129

Microgenics Corporation

Ethanol (ETOH) IVD, calibrator
Primary Device ID00884883005129
NIH Device Record Key1c55b700-f7c3-42b3-b390-60074eddf0be
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Negative Alcohol Calibrator
Version Model Number1405
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
GS100884883005129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKCAlcohol Control Materials
DNNCalibrators, Ethyl Alcohol

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-01
Device Publish Date2016-09-12

On-Brand Devices [DRI Negative Alcohol Calibrator]

008848830115640311
008848830051291405

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