DRI Ecstasy 1000 ng/mL Calibrator

GUDID 00884883001374

Microgenics Corporation

Amphetamine/methamphetamine group IVD, calibrator
Primary Device ID00884883001374
NIH Device Record Key19e95d30-bb2f-4c12-a91b-f0b93d415443
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Ecstasy 1000 ng/mL Calibrator
Version Model Number100079
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883001374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DLJCalibrators, Drug Specific

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

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