CEDIA Amphetamine/Ecstasy Assay

GUDID 00884883012523

Microgenics Corporation

Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883012523
NIH Device Record Key18a72bf2-4f0c-4458-94d2-63a29f61163a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Amphetamine/Ecstasy Assay
Version Model Number10016417
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
GS100884883012523 [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 Date2016-10-25

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