MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control

GUDID 00884883011991

Microgenics Corporation

Multiple cardiac marker IVD, control
Primary Device ID00884883011991
NIH Device Record Key00b7c5cc-f223-45db-b636-6a457390f0d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control
Version Model NumberOCRD-SP
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
GS100884883011991 [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 Date2017-04-26

On-Brand Devices [MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control]

00884883012004OCRD-MP
00884883011991OCRD-SP
00884883011984OCRD-303
00884883011977OCRD-202
00884883011960OCRD-101
00884883011953OCRD-L
00884883011946OCRD-UL

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