FDA.reportPublic FDA data

Sensititre

Primary DI
05032384571611
Brand
Sensititre
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
YO4IVD
Published
2024-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NGZSusceptibility Test Plate, Antifungal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGZSusceptibility Test Plate, AntifungalMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231433000The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific2023-08-31NGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384571611PrimaryGS10
05032384571321Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384571611050323845716115032384571611
05032384571321050323845713215032384571321

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antibacterial susceptibility testing kit IVDA collection of reagents and other associated materials containing a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection), that may be impregnated on individual testing discs or in a strip format, intended to be used to determine the antibacterial susceptibility profile of a specific bacterial microorganism (excluding mycobateria), in a clinical specimen and/or culture isolate.

Contacts#

Phone, Email table
PhoneEmail
8006427029info.Trek.US@thermofisher.com

Regulatory Flags#

DUNS number
298203498
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05032384574230CMC1NJNFCMC1NJNF2026-05-06
05032384569588STP8FSTP8F2026-03-19
05032384474370SensititreGPN3F2025-04-11
05032384490813SensititreGPALL3F2025-04-11
05032384500406SensititreFDANDPF2025-04-11
05032384522941SensititreGN7F2025-04-11
05032384574384SensititreHPB22025-04-11
05032384576050SensititreARUP1MDF2025-04-11
05032384571499SensititreGPN3F2025-04-11
05032384571482SensititreGPALL3F2025-04-11
05032384571574SensititreFDANDPF2025-04-11
05032384571758SensititreGN7F2025-04-11
05032384580132SensititreHPB22025-04-11
05032384580613SensititreARUP1MDF2025-04-11
05032384551811SensititreSTP7F 2024-07-24
05032384557615SensititreMDRGN3F 2024-07-24
05032384561742SensititreGNUR5F2024-07-24
05032384571413SensititreYO3IVD2024-07-25
05032384571451SensititreYO2IVD2024-07-25
05032384571536SensititreESB1F2024-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384571413SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384571451SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384503513SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384474561SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-25
05032384571789SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
05032384571321SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
05032384511419SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
00848838036835SENSITITRE YEASTONE SUSCEPTIBILITY PLATESREMEL, INC.NGZ2023-06-20
03573026623838ETEST® Fluconazole (FL)BIOMERIEUX SANGZ2021-12-03
03573026623562ETEST®BIOMERIEUX SANGZ2021-12-03
03573026550363ETEST® Itraconazole (IT)BIOMERIEUX SANGZ2019-10-22
03573026616014Etest® ITRACONAZOLEBIOMERIEUX SANGZ2019-10-22
03573026619350VITEK® 2 AST-YS09BIOMERIEUX , INC.NGZ2019-04-05
03573026619268VITEK 2 ® AST-YS09BIOMERIEUX , INC.NGZ2019-04-05
03573026529758VITEK® 2 AST-YS05BIOMERIEUX , INC.NGZ2017-01-09
03573026373047VITEK® 2 AST-YS05BIOMERIEUX , INC.NGZ2017-01-09
03573026550158ETEST® Fluconazole (FL)BIOMERIEUX SANGZ2016-12-12
03573026550165ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-12-12
03573026550516ETEST® Voriconazole (VO)BIOMERIEUX SANGZ2016-12-12
03573026377731ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-12-12
03573026377717Etest® FLUCONAZOLEBIOMERIEUX SANGZ2016-12-12
03573026378974Etest® VORICONAZOLEBIOMERIEUX SANGZ2016-12-12
03573026548889Etest® FLUCONAZOLEBIOMERIEUX SANGZ2016-11-18
03573026548896ETEST® Flucytosine (FC)BIOMERIEUX SANGZ2016-11-18
03573026549091Etest® ITRACONAZOLEBIOMERIEUX SANGZ2016-11-18
03573026253318Etest® ITRACONAZOLEBIOMERIEUX SANGZ2016-11-18
03573026252885Etest® FLUCYTOSINEBIOMERIEUX SANGZ2016-11-18
M578YO2IVD2SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2016-09-24
M578YO3IVD2SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2016-09-24
00848838018817NAREMEL, INC.NGZ2016-09-24