DRI Ecstasy Plus Assay

GUDID 00884883006751

Microgenics Corporation

Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883006751
NIH Device Record Key372f1240-7be6-4db3-8ce0-a96bc8dca22f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Ecstasy Plus Assay
Version Model Number10024631
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
GS100884883006751 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-29
Device Publish Date2018-09-27

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