DRI THC 40 ng/mL Urine Control

GUDID 00884883004993

Microgenics Corporation

Cannabinoid IVD, control
Primary Device ID00884883004993
NIH Device Record Keydafe6c7a-75ef-4574-88ca-42f6ba692dc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI THC 40 ng/mL Urine Control
Version Model Number1401
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100884883004993 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-11
Device Publish Date2017-10-19

On-Brand Devices [DRI THC 40 ng/mL Urine Control]

008848830114410170
008848830049931401

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