MAS Tox Control Liquid Assayed Toxicology Control

GUDID 00884883003880

Microgenics Corporation

Multiple-therapy therapeutic drug monitoring IVD, control
Primary Device ID00884883003880
NIH Device Record Key90f5581a-6885-40cf-a0a2-c956ef2688c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS Tox Control Liquid Assayed Toxicology Control
Version Model Number10011608
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883003880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DIFDrug Mixture Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-29
Device Publish Date2018-01-25

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