DRI Ethyl Alcohol Assay

GUDID 00884883012486

Microgenics Corporation

Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
Primary Device ID00884883012486
NIH Device Record Key77133285-f70a-47ab-8bb9-15bc90ebdf9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Ethyl Alcohol Assay
Version Model Number10016397
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
GS100884883012486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet

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 [DRI Ethyl Alcohol Assay]

0088488301248610016397
008848830028900038
008848830010080037

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