VITEK® 2 AST-XN30

GUDID 03573026635442

VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli

BIOMERIEUX , INC.

General-microorganism antimicrobial susceptibility culture medium IVD
Primary Device ID03573026635442
NIH Device Record Key6fb7e30d-005e-4018-9a3c-06817da34336
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITEK® 2 AST-XN30
Version Model NumberVITEK® 2 AST-XN30
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026634896 [Primary]
GS103573026635442 [Package]
Contains: 03573026634896
Package: [20 Units]
In Commercial Distribution

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 Date2023-07-10
Device Publish Date2023-06-30

Devices Manufactured by BIOMERIEUX , INC.

03573026641337 - VITEK® 2 AST-N8152024-11-21 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
00860007326905 - VITEK® REVEAL™2024-10-17 The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details f
00860007326912 - VITEK® REVEAL™ SEALER2024-10-17 The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
03573026638900 - VITEK® REVEAL™ SENSOR PANEL2024-10-17 The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria
03573026636357 - VITEK® 2 AST-N8142023-12-14 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026635978 - VITEK® 2 AST-N8092023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636142 - VITEK® 2 AST-N8112023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636296 - VITEK® 2 AST-N8122023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin

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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