MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control

GUDID 00884883001848

Microgenics Corporation

Mycophenolate therapeutic drug monitoring IVD, control
Primary Device ID00884883001848
NIH Device Record Keyee627b4d-31e1-45a4-9b94-e02bccabc9b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control
Version Model Number100280
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883001848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-01
Device Publish Date2016-09-12

On-Brand Devices [MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control]

00884883001848100280
00884883001831100279
00884883001824100278

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