QMS Quinidine Immunoassay Calibrator Set

GUDID 00884883006003

Microgenics Corporation

Quinidine therapeutic drug monitoring IVD, calibrator
Primary Device ID00884883006003
NIH Device Record Keybd71a3de-6eab-474b-8135-33fbc0a07ffe
Commercial Distribution StatusIn Commercial Distribution
Brand NameQMS Quinidine Immunoassay Calibrator Set
Version Model Number0374165
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
GS100884883006003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DLJCalibrators, Drug Specific
LBZEnzyme Immunoassay, Quinidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-21
Device Publish Date2016-09-22

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