VITEK®2

GUDID 03573026609399

CD WITH 9.02 software version

BIOMERIEUX , INC.

Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
Primary Device ID03573026609399
NIH Device Record Key115c307b-0e21-4933-9cf4-736fadf97a86
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITEK®2
Version Model Number9.02.0
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
GS103573026609399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-20
Device Publish Date2019-06-12

On-Brand Devices [VITEK®2]

03573026609399CD WITH 9.02 software version
03573026463533VITEK 2.0 0.45% SALINE INDIVIDUAL BAG
03573026555504VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
03573026619060VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
03573026206765VITEK®2 60 is an automated system that performs bacterial ID and AST. A total of 60 ID and/o
03573026145804VITEK®2 60 is an automated system that performs bacterial ID and AST. A total of 60 ID and/o
03573026206789VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings

Trademark Results [VITEK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VITEK
VITEK
87490229 5531511 Live/Registered
bioMerieux Inc.
2017-06-15
VITEK
VITEK
86243079 not registered Dead/Abandoned
MENDEZ, LUIS ANTONIO MONTANA
2014-04-04
VITEK
VITEK
79239620 not registered Live/Pending
OOO "Business-Aliance"
2018-06-22
VITEK
VITEK
79043404 3705393 Dead/Cancelled
OOO "Business-Aliance"
2007-03-06
VITEK
VITEK
79002691 not registered Dead/Abandoned
OOO "Business-Aliance"
2004-05-17
VITEK
VITEK
78539879 not registered Dead/Abandoned
Vitek MD. Ph.D., Jiri
2004-12-29
VITEK
VITEK
78458972 not registered Dead/Abandoned
Eric M. Meckes
2004-07-29
VITEK
VITEK
78219204 not registered Dead/Abandoned
Meckes, Eric M.
2003-02-26
VITEK
VITEK
78064372 not registered Dead/Abandoned
International Trade Distributors, Inc.
2001-05-18
VITEK
VITEK
77765610 3820520 Live/Registered
VITEK INDUSTRIAL PRODUCTS, INC.
2009-06-22
VITEK
VITEK
77531903 4362649 Live/Registered
bioMérieux, Inc.
2008-07-25
VITEK
VITEK
75252806 not registered Dead/Abandoned
bioMerieux Vitek, Inc.
1997-03-06

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