QMS Zonisamide Assay

GUDID 00884883012714

Microgenics Corporation

Zonisamide therapeutic drug monitoring IVD, kit, fluorescent immunoassay
Primary Device ID00884883012714
NIH Device Record Key4fc478bc-aa96-41e5-a41c-c3e0d0aa5af9
Commercial Distribution StatusIn Commercial Distribution
Brand NameQMS Zonisamide Assay
Version Model Number10017230
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
GS100884883012714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWMImmunoassay, Anti-Seizure Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-14
Device Publish Date2016-09-12

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