MAS PAR TDM Liquid Assayed Therapeutic Drug Control

GUDID 00884883002418

Microgenics Corporation

Multiple-therapy therapeutic drug monitoring IVD, control
Primary Device ID00884883002418
NIH Device Record Key1ae2fbd0-aba4-4bf7-944e-329064640666
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS PAR TDM Liquid Assayed Therapeutic Drug Control
Version Model NumberPTD1-1001
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
GS100884883002418 [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 Date2017-04-26

On-Brand Devices [MAS PAR TDM Liquid Assayed Therapeutic Drug Control]

00884883011694PTD-S1
00884883002432PTD3-3003
00884883002425PTD2-2002
00884883002418PTD1-1001

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