CEDIA Bupernorphine II Assay

GUDID 00884883003873

Microgenics Corporation

Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883003873
NIH Device Record Keyeeb929dc-f887-42b4-8711-bc3b55bd5abb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Bupernorphine II Assay
Version Model Number10020849
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
GS100884883003873 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-12

On-Brand Devices [CEDIA Bupernorphine II Assay]

0088488300475710020850
0088488300387310020849

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