FDA.reportPublic FDA data

Sensititre

Primary DI
05032384505913
Brand
Sensititre
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
CMC1GNCC
Published
2024-07-24
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
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152774000The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mLThermo Fisher Scientific2015-12-21JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384571765PrimaryGS10
05032384505913Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384571765050323845717655032384571765
05032384505913050323845059135032384505913

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.

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
05032384569588STP8FTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2026-03-19
15099590798970MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.LRG2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.LRG2025-12-08
05032384474370SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384490813SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384500406SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384522941SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384574384SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2025-04-11
05032384526147SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-25
05032384539468SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-25
05032384566815SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-25
05032384571659SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-25
05032384511013SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384512621SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384525829SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384530021SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384540020SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384548620SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384551811SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384557615SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571369SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571543SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571567SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571598SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571765SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24
05032384571918SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLRG2024-07-24