DRI Ecstasy Assay

GUDID 00884883001350

Microgenics Corporation

Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883001350
NIH Device Record Key7f4ca783-6d93-4f97-b3f9-87b637f49926
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Ecstasy Assay
Version Model Number100075
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
GS100884883001350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

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 Ecstasy Assay]

0088488301134210014681
00884883002883100076
00884883001350100075

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