FDA Registration
Active
🇬🇧 United Kingdom
TREK DIAGNOSTIC SYSTEMS, LTD.
Reg #: 8021914
·
FEI: 3002806332
·
Expires 2026
Products
11
Proprietary Names
111
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- TREK DIAGNOSTIC SYSTEMS, LTD.
- Registration Number
- 8021914
- FEI Number
- 3002806332
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Units 17 - 19, Birches Industrial Estate
- City
- East Grinstead West Sussex
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K960235
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
US Agent
- Business Name
- Remel Inc.
- Contact Name
- Joel Mathew
- Address
- 12076 Santa Fe Trail
- City
- Lenexa
- State
- KS
- ZIP
- 66215
- Country
- US
- [email protected]
- Phone
- 978 9074417
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Manual Antimicrobial Susceptibility Test Systems | JWY | Class 2 | Microbiology | No | 2016-08-12 |
| Susceptibility Test Plate, Antifungal | NGZ | Class 2 | Microbiology | No | 2023-12-10 |
| Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | LRG | Class 2 | Microbiology | No | 2022-06-09 |
| Panels, Test, Susceptibility, Antimicrobial | LTT | Class 2 | Microbiology | No | 2022-06-09 |
| Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | JTZ | Class 2 | Microbiology | No | 2011-12-13 |
| Susceptibility Test Cards, Antimicrobial | LTW | Class 2 | Microbiology | No | 2015-11-18 |
| Gram Negative Identification Panel | LQM | Class 1 | Microbiology | No | 2016-08-31 |
| System, Transport, Aerobic | JTW | Class 1 | Microbiology | No | 2016-08-12 |
| Reagent/Device, Inoculum Calibration | LIE | Class 2 | Microbiology | No | 2016-01-15 |
| Gram Positive Identification Panel | LQL | Class 1 | Microbiology | No | 2011-12-19 |
| Nephelometer, For Clinical Use | JQX | Class 1 | Clinical Chemistry | No | 1998-09-25 |
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 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 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
SENSITITRE SUSCEPTABILITY PLATES, Ampicillin/Sulbactam, Cefonicid, Ciproflaxacin
Sensititre GP Panel
MB1561A Microbact Staph 12S
MB1588A Microbact Staph Fast Blue Reagent
Sensititre GPID Identification, Non Fastidious, GramPositive
Nephelometer
Sensititre 20-24 hour Haemophilus influenzae/Strep. pneumoniae(HP) MIC/BP Susceptibility System with Linezolid 0.12-32
SENSITITRE HP - Haemophilus - Pneumococcus MIC PlatE
SENSITITRE SUSCEPTIBILITY PLATES (CEFOTAXIME)
SENSITITRE SUSCEPTIBILITY PLATES (MOXIFLOXCACIN)
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (Ofloxacin, Cefotetan, Amoxicillin/Clavulanic Acid, Ampicillin/Sulbactam)
CMC1GPUF
Susceptibility Test Panel for Vancomycin VRSA 1-128jg/ml
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (CEFTAZIMDIME, CEFTAZIMDIME/CLAVULANIC ACID)
SENSITITRE SUSCEPTIBILITY PLATES (VORICONIZOLE)
CMC1YOGV
GNU1F
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin
V3030 Sensititre OptiRead
Thermo Scientific Sensititre ARIS HiQ
Sensititre Haemophilus/S. pneumoniae (HP) MIC Susceptibility plate
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System
CMC1OUPF
Sensititre 18-24 hour Susceptibility plates
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility