BACT/ALERT VIRTUO

GUDID 03573026614546

Firmware update for VIRTUO Release R 3.0

BIOMERIEUX , INC.

Blood culture analyser IVD, automated
Primary Device ID03573026614546
NIH Device Record Keye72d60f7-d34b-4db4-b71a-5855d3bab62b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBACT/ALERT VIRTUO
Version Model NumberR3
Company DUNS086785110
Company NameBIOMERIEUX , INC.
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026614546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDBSystem, blood culturing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-04
Device Publish Date2020-08-27

Devices Manufactured by BIOMERIEUX , INC.

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