VITEK® 2 COMPACT

GUDID 03573026136789

VITEK® 2 COMPACT 30 is an automated system that performs bacterial ID and AST. A total of 30 ID and/or AST cards can be processed simultaneously per run.

BIOMERIEUX , INC.

Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD
Primary Device ID03573026136789
NIH Device Record Key0ac2c927-dc04-495a-9761-6db642dac14f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITEK® 2 COMPACT
Version Model Number27530
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026136789 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-04-28
Device Publish Date2016-09-14

On-Brand Devices [VITEK® 2 COMPACT]

03573026220624VITEK® 2 COMPACT 15 is an automated system that performs bacterial ID and AST. A total of 15 I
03573026136796VITEK® 2 COMPACT 60 is an automated system that performs bacterial ID & AST. A total of 60 ID
03573026136789VITEK® 2 COMPACT 30 is an automated system that performs bacterial ID and AST. A total of 30 I

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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