CEDIA Methamphatemine OFT Assay

GUDID 00884883011083

Microgenics Corporation

Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883011083
NIH Device Record Keyde7c5a8c-d21f-4167-8f85-0327d1294029
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Methamphatemine OFT Assay
Version Model Number10014949
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
GS100884883011083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DLJCalibrators, Drug Specific
LAFGas Chromatography, Methamphetamine

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 Date2016-09-21

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