DRI Benzodiazepine Assay

GUDID 00884883011649

Microgenics Corporation

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883011649
NIH Device Record Key39721607-cc35-4b8a-8340-3f53b0b76e71
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Benzodiazepine Assay
Version Model Number10015644
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
GS100884883011649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXMEnzyme Immunoassay, Benzodiazipine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-15
Device Publish Date2016-09-22

On-Brand Devices [DRI Benzodiazepine Assay]

0088488301164910015644
008848830028450040
008848830025480039

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