TREK DIAGNOSTIC SYSTEMS, LTD.

FDA Device Registration & Listing · East Grinstead West Sussex, GB · Registration 8021914

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8021914
FEI Number
3002806332
Entity Name
TREK DIAGNOSTIC SYSTEMS, LTD.
City/State/Country
East Grinstead West Sussex, GB
Establishment Address
Units 17 - 19, Birches Industrial Estate, East Grinstead West Sussex RH19 1XZ, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Thermo Fisher Scientific (Owner Number: 2517925)
Owner / Operator Contact Address
168 Third Avenue, --, Waltham, MA 02451, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232310
PMA Number
N/A

All Registered Proprietary Names

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (CEFPODOXIME) The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 008-8ug/mL STP8F Sensititre Haemophilus influenza/Streptococcus pneumoniae MIC Susceptibility Plate SENSITITRE SUSCEPTIBILITY PLATES (PENICILLIN, CEFTRIAXONE, CHLORAMPHENICOL, ERYTHROMYCIN, TETRACYALINE, TRIM/SULF) Sensititre Susceptibility Plates SENSITITRE SUSCEPTIBILITY PLATES (DORIPENEM) CMC1MDNF Sensititre 20-24 hour H. influenzae/S. pneumoniae MIC or BP Susceptibility System with Lefamulin dilution 008-16 ug/mL Sensititre 18-24 hours Susceptibility Plates (OMADACYCLINE) OMADFAST SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (LINEZOLID) CMC1OUNF Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam durlobactam in dil range 015/4-32/4 µg/mL ARUP1MDF MDRGN4F SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (PIPERACILLIN/TAZOBACTAM) SENSITITRE SUSCEPTIBILITY PLATES (VANCOMYCIN) Mueller Hinton Broth T3462-05 MUELLER-HINTON BROTH W/TES 5ml 100/BOX T3462 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES CP112-10 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood CP11410 Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood T3491 Sensititre Saline- Tween w/ Glass Beads T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC T3441 Sensititre Middlebrook 7H9 Broth w/OADC SENSITITRE SUSCEPTIBILITY PLATES (AMOXICILLIN/CLAVULANIC ACID) Sensititre 18-24 hr MIC or BP Susceptibility System with Eravacycline in the dilution range of 008-16 microg/mL SENSITITRE VIZION SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (DOXYCYCLINE) CMC4VGPF CMC1AXPF Sensititre Susceptibility plates MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST SENSITITRE SUSCEPTIBILITY PLATES (CLINDAMYCIN) Sensititre H. influenzae/Strep pneumoniae MIC or Breakpoint Susceptibility System with Imipenem 015 - 4 ?g/ml CMC5VGPF CMC6VGNF SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (CEFTAZIMDIME/AVIBACTAM) CMC5VGNF Sensititre 18-24 hour MIC or BP System with Moxifloxacin range of 008-16ug/ml HPB1 Sensititre™ Haemophilus and Streptococcus pneumoniae MIC Plate T3470 Sensititre HTM Broth T3462-10 Sensititre Cation Adjusted Mueller- Hinton Broth w/TES Sensititre Susceptibility Plates - Multiple SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) SENSITITRE SUSCEPTIBILITY PLATES (AZRITHROMYCIN, CEFEPIME, CEFPODOXIME, CLARITHROMYCIN, LEVOFLOXACIN, MEROPENIM, PIP/TAZ SENSITITRE GNID IDENTIFICATION NON FASTIDIOUS GRAM NEGATIVE Sensititre Haemophilus influenza/Streptococcus pneumoniae MIC Susceptibility Plate SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (DAPTOMYCIN) SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MEROPENEM) SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (LOMEFLOXACIN) Sensititre 18-24 hour MIC or BP Susceptibility System with Vancomycin 0.25-128 ug/mL Sensititre 18-24 hour MIC or BP Susceptibility System with Ceftobiprole 008-16 µg/mL Sensititre AIM™ inoculation system Sensititre 18 – 24 hour Susceptibility MIC Plates SENSITITRE SUSCEPTIBILITY PLATES (CLARYTHROMYCIN) SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (CEFEPIME) The Sensititre® 18-24 MIC or BP Susceptibility System with D-test 1 and 2 broth test for Staphylococcus sp. CMC3VGPF Sensititre GN Panel Sensititre 20-24 hour H. influenzae/Strep.. pneumoniae(HP)MIC or BP Susceptibility System with ceftriaxone 015 - 2 ug/ SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (ERTAPENEM) SENSITITRE SUSCEPTIBILITY PLATES (FLUCONAZOLE, ITRACONIZOLE, 5-FLUCYTOSINE,) Y3462 Sensititre YeastONE Broth SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (CEFOXITIN SCREEN) Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol (03 – 64 ?g/mL) SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (TiGECYCLINe) MEROVAB Sensititre 18-24 hour MIC or BP Susceptibility System with Meropenem/Vaborbactam (008/8-18/8 ug/mL) Sensititre 20-24 hour Haemophilus influenzae/S. pneumoniae (HP) MIC/BP Susceptibility System Penicillin 015-32 ug/mL SENSITITRE SUSCEPTIBILITY PLATES (ERTAPENEM) Sensititre Susceptibility plates SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES - STREPTOMYCIN CMC1GPVF Sensititre AIM™ SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (TELAVANCIN) CMC5MDOH SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (LEVOFLOXACIN) Thermo Scientific Sensititre ARIS HiQ System CMC6AFLF CMC7AFLF Sensititre® 18 -24 hour MIC or Breakpoint Susceptibility System" with Minocycline Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 03/4-2 Sensititre 20 - 24 hour H.influenzae/S.pneumoniae MIC or BP Susceptibility System with Omadacycline 008- 32?g/mL HPB2 Sensititre H. influenzae/Strep pneumoniae MIC or BP Susceptibility System with Ceftolozane-tazobactam 03/4-64/4ug/ml

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
NGZ Susceptibility Test Plate, Antifungal Microbiology Class 2 866.1640 2023-12-10
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2022-06-09
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2022-06-09
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2022-06-09
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-11-18
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-11-18
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-11-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2022-06-07
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2022-06-07
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2022-06-07
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2019-07-08
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2019-07-08
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2019-07-08
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2014-07-14
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2023-12-10
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Microbiology Class 2 866.1700 2011-12-13
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2023-09-22
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2023-09-22
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2023-09-22
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2011-12-13
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-08-12
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2015-11-18
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-11-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-11-18
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-11-18
NGZ Susceptibility Test Plate, Antifungal Microbiology Class 2 866.1640 2011-12-13
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2024-06-05
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2024-06-05
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2024-06-05
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-08-12
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2025-05-28
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2025-05-28
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2025-05-28
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2014-08-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2014-08-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2011-12-13
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LQM Gram Negative Identification Panel Microbiology Class 1 866.2660 2016-08-31
LTW Susceptibility Test Cards, Antimicrobial Microbiology Class 2 866.1640 2015-11-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-11-18
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-11-18
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-11-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-08-12
JTW System, Transport, Aerobic Microbiology Class 1 866.2900 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2018-03-20
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2018-03-20
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2018-03-20
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2025-06-05
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2025-06-05
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2025-06-05
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2025-06-05
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2025-06-05
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2025-06-05
LIE Reagent/Device, Inoculum Calibration Microbiology Class 2 866.1640 2016-01-15
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-01-15
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-01-15
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
NGZ Susceptibility Test Plate, Antifungal Microbiology Class 2 866.1640 2014-07-14
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2024-03-06
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2024-03-06
LQM Gram Negative Identification Panel Microbiology Class 1 866.2660 2011-12-19
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2025-06-05
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2025-06-05
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2025-06-05
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
NGZ Susceptibility Test Plate, Antifungal Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2020-04-27
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2020-04-27
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2020-04-27
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2023-09-22
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2023-09-22
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2023-09-22
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2025-06-05
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2025-06-05
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2025-06-05
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2015-11-18
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2015-11-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2015-11-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-11
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2014-08-18
LIE Reagent/Device, Inoculum Calibration Microbiology Class 2 866.1640 2014-08-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2014-08-18
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2016-08-12
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2016-08-12
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2019-12-16
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2024-07-24
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2024-07-24
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2020-04-24
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2023-09-22
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2023-09-22
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2023-09-22
LTT Panels, Test, Susceptibility, Antimicrobial Microbiology Class 2 866.1640 2024-06-05
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Microbiology Class 2 866.1640 2024-06-05
JWY Manual Antimicrobial Susceptibility Test Systems Microbiology Class 2 866.1640 2024-06-05

Official Correspondent

No official correspondent registered.

US Agent Details

Joel Mathew Business: Remel Inc. Email: joel.mathew@thermofisher.com Phone: (978) 9074417

Related Public Records

Same Entity

Thermo Fisher Scientific
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010455511 Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd Suzhou Jiangsu, CN
3006190736 LABOMEX MBP TIJUANA Baja California, MX
2517925 FISHER SCIENTIFIC COMPANY L.L.C. PITTSBURGH, PA, US
3006440892 OXOID AUSTRALIA PTY LIMITED THEBARTON South Australia, AU
1314344 Nalge Nunc International Corporation Rochester, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K944753 Radiometer America, Inc. SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP 1995-02-24
K232967 bioMerieux, Inc. VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) 2024-06-12
K010508 Pasco Laboratories, Inc. PASCO MIC AND MIC/ID PANELS 2001-04-23
K111394 Siemens Healthcare Diagnostics, Inc. MICROSCAN MICROSTEP 2011-06-22
K812581 Uti-Tect, Inc. SENSI-TECT 1981-09-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0015-2008 Thermo Fisher Scientific 1
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021914. Last updated year: 2026. Please use registration number 8021914 when referencing this establishment in official correspondence.
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