MAS CardioImmune XL Liquid Assayed Cardiac Marker Control

GUDID 00884883003606

Microgenics Corporation

Multiple cardiac marker IVD, control
Primary Device ID00884883003606
NIH Device Record Key81d6b642-dfc4-4560-af8a-1f92240a1b40
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS CardioImmune XL Liquid Assayed Cardiac Marker Control
Version Model NumberCAI-XL4
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
GS100884883003606 [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 CardioImmune XL Liquid Assayed Cardiac Marker Control]

0088488300439910014182
0088488300438210014181
0088488300437510014180
0088488300436810014179
00884883003613CAI-XLS
00884883003606CAI-XL4
00884883002371CAI-XLL
00884883002364CAI-XL3
00884883002357CAI-XL2
00884883002340CAI-XL1

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