CEDIA Methamphetamine OFT Assay

GUDID 00884883000827

Microgenics Corporation

Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883000827
NIH Device Record Key854133ad-e164-4c62-9b93-e064d5f5abc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Methamphetamine OFT Assay
Version Model Number10021753
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
GS100884883000827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAFGas Chromatography, Methamphetamine

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 Methamphetamine OFT Assay]

0088488300082710021753
0088488300023010018595

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