FDA.reportPublic FDA data

Sensititre

Primary DI
05032384474561
Brand
Sensititre
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
YO2IVD
Published
2024-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K991810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991810000MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TESTTrek Diagnostic Systems, Inc.2001-10-09NGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384571451PrimaryGS10
05032384474561Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384571451050323845714515032384571451
05032384474561050323844745615032384474561

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type pathogen antimicrobial susceptibility testing kit IVDA collection of reagents and other associated materials containing a range of antimicrobial agents e.g., (antibacterial/antibiotic, antifungal/antimycotic and/or antimycobacterial) that may be impregnated on individual testing discs, in a strip format or a microplate, intended to be used to determine the susceptibility profile of a specific pathogen (bacterium, fungus and/or Mycobacterium), in a clinical specimen and/or culture isolate.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
298203498
Device count
10
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
true
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
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
05032384571611SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDNGZ2024-07-24
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