FDA.reportPublic FDA data

VITEK® 2 AST-XN19

Primary DI
03573026628123
Brand
VITEK® 2 AST-XN19
Company
BIOMERIEUX , INC.
Model
VITEK® 2 AST-XN19
Device description
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
Published
2022-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LTTPanels, test, susceptibility, antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTTPanels, Test, Susceptibility, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040845000VITEK 2 ESBL TESTbioMerieux, Inc.2004-06-08LON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026628123PackageGS120In Commercial Distribution
03573026628116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026628123035730266281233573026628123
03573026628116035730266281163573026628116

GMDN Terms#

Term, Definition table
TermDefinition
General-microorganism antimicrobial susceptibility culture medium IVDA non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
086785110
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026628116VITEK® 2 AST-XN19VITEK® 2 AST-XN192022-04-15
03573026618285VITEK10.02025-05-15
03573026612047BACT/ALERT® BPABACT/ALERT® BPA2020-06-26
03573026614157BACT/ALERT® BPNBACT/ALERT® BPN2020-06-26
03573026613914VITEK® 2 Knowledge base update 09.039.032022-04-11
03573026615499VITEK® COMPACT PRO4234652025-05-15
03573026222222VITEK® 2 DENSICHEK® Plus Standards Kit212552016-11-30
03573026609399VITEK® 2 Software 09.029.02.02019-06-12
03573026530808VITEK® 2 AST-GP74VITEK® 2 AST-GP742017-01-09
03573026595722BACT/ALERT® PFBACT/ALERT® PF2020-04-22
03573026595906BACT/ALERT® FABACT/ALERT® FA2020-04-23
03573026595920BACT/ALERT® FNBACT/ALERT® FN2020-04-23
03573026222239DENSICHEK® Plus212502016-11-30
03573026530914VITEK® 2 AST-GN68VITEK® 2 AST-GN682017-01-09
03573026647780VITEK® 2 AST-N816VITEK® 2 AST-N8162025-11-21
03573026638887VITEK® REVEAL™ BC GN02-ASTVITEK® REVEAL™ BC GN02-AST2024-10-09
03573026613112PREVI™ Isola Applicator CartrigePREVI™ Isola Applicator Cartrige2020-06-26
03573026145842VITEK®227222R2016-09-14
03573026553968VITEK®28.012017-01-03
03573026619060VITEK®29.01.12019-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384569588STP8FTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2026-03-19
15099590798970MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.LTT2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.LTT2025-12-08
05032384490813SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2025-04-11
05032384500406SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2025-04-11
05032384522941SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2025-04-11
05032384574384SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2025-04-11
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LTT2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LTT2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LTT2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LTT2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LTT2024-12-20
00850031114043AST AnalyzerSelux Diagnostics, Inc.LTT2024-12-20
00850031114067PBC Separator with Selux AST SystemSelux Diagnostics, Inc.LTT2024-12-20
00850031114135Selux AST Gram Positive PanelsSelux Diagnostics, Inc.LTT2024-12-17
05032384539468SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-25
05032384566815SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-25
05032384511013SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24
05032384512621SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24
05032384525829SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24
05032384540020SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24
05032384551811SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24
05032384557615SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24
05032384561742SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24
05032384571369SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24
05032384571567SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTT2024-07-24