MAS Cardioimmune Ultra Low

GUDID 00884883003620

Microgenics Corporation

Troponin T/Troponin I IVD, control
Primary Device ID00884883003620
NIH Device Record Keya9022404-728a-4328-acc5-5d62f0d89680
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS Cardioimmune Ultra Low
Version Model NumberCAI-UL
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
GS100884883003620 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-10
Device Publish Date2018-08-21

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