QMS Zonisamide Immunoassay Calibrator

GUDID 00884883011236

Microgenics Corporation

Zonisamide therapeutic drug monitoring IVD, calibrator
Primary Device ID00884883011236
NIH Device Record Keyf18ac650-e9e3-4dba-bb6c-d0207c6caae8
Commercial Distribution StatusIn Commercial Distribution
Brand NameQMS Zonisamide Immunoassay Calibrator
Version Model Number0373381
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100884883011236 [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 Number5
Public Version Date2019-07-09
Device Publish Date2016-09-24

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