DRI Cotinine Assay

GUDID 00884883002876

Microgenics Corporation

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883002876
NIH Device Record Keyd30415e6-42f4-4d69-ba49-dd135032571f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Cotinine Assay
Version Model Number0395
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100884883002876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKUEnzyme Immunoassasy, Nocotine And Nicotine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-09
Device Publish Date2016-09-24

On-Brand Devices [DRI Cotinine Assay]

0088488301290510018516
008848830028760395
008848830010530394

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