FDA.reportPublic FDA data

Sensititre

Primary DI
05032384571819
Brand
Sensititre
Company
TREK DIAGNOSTIC SYSTEMS LIMITED
Model
OMADFAST
Published
2024-03-06
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
JWYManual Antimicrobial Susceptibility Test Systems
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183033000
K183324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183033000Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/mlThermo Fisher Scientific2019-01-04JWY
K183324000Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mLThermo Fisher Scientific2019-02-15JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384522934PrimaryGS10
05032384571819Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384522934050323845229345032384522934
05032384571819050323845718195032384571819

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
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