DRI Barbiturate Serum Tox Assay

GUDID 00884883005587

Microgenics Corporation

Barbiturate IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883005587
NIH Device Record Key076b1e8a-910b-46b6-8ba1-a3b4b5304496
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Barbiturate Serum Tox Assay
Version Model Number0911
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
GS100884883005587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DISEnzyme Immunoassay, Barbiturate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

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