CEDIA Amphetamines/Ecstasy Assay

GUDID 00884883001534

Microgenics Corporation

Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883001534
NIH Device Record Key03dde64e-cb96-487e-b423-743b6fa1d776
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Amphetamines/Ecstasy Assay
Version Model Number100103
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
GS100884883001534 [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 Date2016-09-12

On-Brand Devices [CEDIA Amphetamines/Ecstasy Assay]

00884883001541100104
00884883001534100103

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