CEDIA Cannabinoids OFT Assay

GUDID 00884883005747

Microgenics Corporation

Cannabinoid IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883005747
NIH Device Record Key54074b05-08b6-4cfa-9e63-e00331d9721c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Cannabinoids OFT Assay
Version Model Number10014910
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
GS100884883005747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DLJCalibrators, Drug Specific
LDJEnzyme Immunoassay, Cannabinoids

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 Date2016-09-12

On-Brand Devices [CEDIA Cannabinoids OFT Assay]

0088488300574710014910
0088488300085810021737
0088488300021610018585

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