FDA.reportPublic FDA data

VITEK® 2 NH

Primary DI
03573026529710
Brand
VITEK® 2 NH
Company
BIOMERIEUX , INC.
Model
VITEK® 2 NH
Device description
The VITEK® 2 NH Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important Neisseria, Haemophilus and other fastidious GN bacteria
Published
2020-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JSTKIT, FASTIDIOUS ORGANISMS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSTKit, Fastidious OrganismsMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026144357PackageGS120In Commercial Distribution
03573026529710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026144357035730261443573573026144357
03573026529710035730265297103573026529710

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of bacteria belonging to the Haemophilus or Neisseria genera, that have been isolated by culture from a clinical specimen.

Storage And Handling#

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

Regulatory Flags#

DUNS number
086785110
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
03573026144357VITEK® 2 NHBIOMERIEUX , INC.JST2020-06-02
30382902451304BD BBL™ Crystal™ N/HBECTON, DICKINSON AND COMPANYJST2018-05-25
00382902450351BD BBL™ Crystal™ Identification SystemsBECTON, DICKINSON AND COMPANYJST2018-05-25