DRI Opiate Urine Calibrator 3

GUDID 00884883005303

Microgenics Corporation

Opiate/opiate metabolite IVD, calibrator
Primary Device ID00884883005303
NIH Device Record Key97bffe8b-9384-4c2f-a7ab-861d74d338e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Opiate Urine Calibrator 3
Version Model Number1610
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
GS100884883005303 [Primary]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-04
Device Publish Date2016-09-12

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