CEDIA Methadone Metabolite (EDDP) Assay

GUDID 00884883004252

Microgenics Corporation

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883004252
NIH Device Record Key1c96841e-3e36-43bc-971e-58f53c6b81ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Methadone Metabolite (EDDP) Assay
Version Model Number100096
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
GS100884883004252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJREnzyme Immunoassay, Methadone

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 Date2016-09-12

On-Brand Devices [CEDIA Methadone Metabolite (EDDP) Assay]

00884883004252100096
00884883004214100087

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