QMS Quinidine Immunoassay

GUDID 00884883005990

Microgenics Corporation

Quinidine therapeutic drug monitoring IVD, calibrator
Primary Device ID00884883005990
NIH Device Record Key67380187-ba17-4469-be5a-b4a01a9e037c
Commercial Distribution StatusIn Commercial Distribution
Brand NameQMS Quinidine Immunoassay
Version Model Number0373936
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
GS100884883005990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBZEnzyme Immunoassay, Quinidine

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 Date2016-09-26

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