DRI Hydrocodone Calibrator 1000

GUDID 00884883000407

Microgenics Corporation

Opiate/opiate metabolite IVD, calibrator
Primary Device ID00884883000407
NIH Device Record Keyf9fa4eca-cc24-4d06-a456-c5393bdcf3aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Hydrocodone Calibrator 1000
Version Model Number10018082
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
GS100884883000407 [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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