CEDIA Cocaine OFT Assay

GUDID 00884883000223

Microgenics Corporation

Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Primary Device ID00884883000223
NIH Device Record Key8b214aa8-89eb-4b08-a1b4-de91f3b11b83
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Cocaine OFT Assay
Version Model Number10018590
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
GS100884883000223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

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 [CEDIA Cocaine OFT Assay]

0088488301113710014764
0088488300083410021745
0088488300022310018590

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