Acrometrix WNVRNA

GUDID 00884883006270

Microgenics Corporation

West Nile virus nucleic acid IVD, control
Primary Device ID00884883006270
NIH Device Record Key4485c96d-3fd4-4725-bd04-97e80245f7e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcrometrix WNVRNA
Version Model Number960500
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100884883006270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYZKit, Test (Donors), For Bloodborne Pathogen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-18
Device Publish Date2018-09-17

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