CEDIA Amphetamine OFT Assay

GUDID 00884883000841

Microgenics Corporation

Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883000841
NIH Device Record Key6fcc2acb-27ad-4123-805f-2c83b8cfc9c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Amphetamine OFT Assay
Version Model Number10021729
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
GS100884883000841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

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 Date2016-10-03

On-Brand Devices [CEDIA Amphetamine OFT Assay]

0088488301106910014947
0088488300084110021729
0088488300020910018579

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