VITEK® MS knowledge base v3.3

GUDID 03573026628154

VITEK® MS knowledge base v3.3

BIOMERIEUX SA

Microbial identification mass spectrometry system IVD
Primary Device ID03573026628154
NIH Device Record Key62511d60-12f8-417e-bf01-1c8d3e47ef0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITEK® MS knowledge base v3.3
Version Model Number3.3
Company DUNS276816717
Company NameBIOMERIEUX SA
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
GS103573026628154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEXSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-22
Device Publish Date2023-11-14

Devices Manufactured by BIOMERIEUX SA

03573026626891 - VIDAS® TBI (GFAP, UCH-L1)2024-11-08 VIDAS TBI (GFAP, UCH-L1) is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the eval
03573026359096 - VITEK® MS-DS2024-04-30 The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method.
03573026359119 - VITEK® MS2024-04-29 MALDI-Tof Mass Spectrometry system used for microbial identification
03573026362843 - VITEK® MS FA2024-04-29 VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used e
03573026619527 - VIDAS® PC SOFTWARE V4.92024-04-29 VIDAS PC V4.9 W10 Software version for clinic
03573026256685 - ETEST® Gentamicin (GM)2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
03573026376604 - ETEST® Amoxicillin (AC)2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
03573026377731 - ETEST® Flucytosine (FC)2024-04-15 Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions

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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