FDA.reportPublic FDA data

Sensititre

Primary DI
05032384557615
Brand
Sensititre
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
MDRGN3F
Published
2024-07-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWYManual Antimicrobial Susceptibility Test Systems
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
LTTPanels, Test, Susceptibility, Antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology2
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsMicrobiology2
LTTPanels, Test, Susceptibility, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192250000Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mLThermo Fisher Scientific2019-10-16JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384557615PrimaryGS10
05032384571727Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384557615050323845576155032384557615
05032384571727050323845717275032384571727

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
05032384561742SensititreGNUR5F2024-07-24
05032384571413SensititreYO3IVD2024-07-25
05032384571451SensititreYO2IVD2024-07-25
05032384571536SensititreESB1F2024-07-24
M578GN2F2SensititreGN2F2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08058951161426Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2026-01-12
08058951161433Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2026-01-12
08058951161266Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2025-11-03
08058951161273Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2025-11-03
08058951161310Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-11-03
08058951161327Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-11-03
08055182878574Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-07-15
08055182873371Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2025-03-19
08055182872954Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2021-10-27
08055182872961Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2021-10-27
08055182872176Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2020-05-15
08055182872183Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2020-05-15
08055182871155Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-12-06
08055182871162Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-12-06
08055182872299Liofilchem MIC Test Strip (MTS)LIOFILCHEM SRLJWY2019-09-16
08055182872305Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-09-16
08055182873821Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-09-12
08055182873838Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-09-12
08055182872473Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-08-30
08055182872480Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-08-30
08055182870615Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-08-02
08055182870622Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-08-02
08055182871698Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-04-19
08055182871704Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-04-19
08055182872565Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-04-19
08055182872572Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-04-19
08055182873043Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-03-04
08055182873050Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-03-04
08055182872381Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-01-31
08055182872398Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-01-31