MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control

GUDID 00884883005341

Microgenics Corporation

Multiple clinical chemistry analyte IVD, control
Primary Device ID00884883005341
NIH Device Record Key358ee909-08eb-4b59-b93e-2ed94c4d182c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control
Version Model NumberOPRO-303
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
GS100884883005341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-26
Device Publish Date2017-05-01

On-Brand Devices [MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control]

00884883005358OPRO-SP
00884883005341OPRO-303
00884883005334OPRO-202
00884883005327OPRO-101

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