MAS Omni-CORE Liquid Assayed Integrated Chemistry Control

GUDID 00884883005419

Microgenics Corporation

Multiple clinical chemistry analyte IVD, control
Primary Device ID00884883005419
NIH Device Record Key6bd9d438-c261-4e61-b43f-373015053ce4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS Omni-CORE Liquid Assayed Integrated Chemistry Control
Version Model NumberOCR-202
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
GS100884883005419 [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 Date2019-04-29
Device Publish Date2017-04-26

On-Brand Devices [MAS Omni-CORE Liquid Assayed Integrated Chemistry Control]

00884883005433OCR-SP
00884883005426OCR-303
00884883005419OCR-202
00884883005402OCR-101

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