DRI Oxycodone Assay

GUDID 00884883002968

Microgenics Corporation

Oxycodone IVD, reagent
Primary Device ID00884883002968
NIH Device Record Key7b314cde-a33c-48c4-a25d-f15ed2ea7858
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Oxycodone Assay
Version Model Number100249
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
GS100884883002968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates
DLJCalibrators, Drug Specific

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-05
Device Publish Date2016-09-22

On-Brand Devices [DRI Oxycodone Assay]

0088488301162510015632
00884883003477100248
00884883002968100249

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