DRI 50 mg/dL Alcohol Control

GUDID 00884883001015

Microgenics Corporation

Ethanol (ETOH) IVD, control
Primary Device ID00884883001015
NIH Device Record Key4b6d3abe-19a9-400b-a3cb-baf1f3235717
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI 50 mg/dL Alcohol Control
Version Model Number0239
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
GS100884883001015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKCAlcohol Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-24
Device Publish Date2017-10-30

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