OXY DRI Oxycodone

GUDID 07613336190791

Microgenics Corporation

Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent Oxycodone IVD, reagent
Primary Device ID07613336190791
NIH Device Record Key736babc5-c33f-4dcd-9480-8ff13291d9e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOXY DRI Oxycodone
Version Model Number09026916 190
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336190791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-03
Device Publish Date2021-10-26

Devices Manufactured by Microgenics Corporation

00884883006027 - Acrometrix BB NAT HBV Positive Control2022-10-17
00884883007376 - MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays2021-11-11
07613336190791 - OXY DRI Oxycodone2021-11-03
07613336190791 - OXY DRI Oxycodone2021-11-03
00884883007383 - MAS anti-HBs Positive Control – For use with Siemens Assays 2021-05-13
00884883007765 - MAS SARS-CoV-2 IgG Positive Control2021-03-15
00884883007772 - MAS SARS-CoV-2 Negative Control2021-03-15
07613336154045 - OXY Oxycodone2020-09-17
00884883007505 - MAS Omni Infectious BSI Positive Control Panel2020-07-08

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