Fast Track Diagnostics

FDA Filings

This page includes the latest FDA filings for Fast Track Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012358485
FEI Number3012358485
NameFAST TRACK DIAGNOSTICS
Owner & OperatorFast Track Diagnostics
Contact Address29,rue henri koch
Esch-Sur-Alzette LU-G 4354 LU
Official Correspondent
  • Christine Wittig
  • 352-281-0981-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address29,rue henri koch
Esch-Sur-Alzette Luxembourg, 4354 LU
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
FAST TRACK DIAGNOSTICS
FTlyo-86 Respiratory pathogens 16 (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-7 Vesicular rash (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-65.2 HPIV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-56.1 HCoV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-48.1 FLU/HRSV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-42.1 Urethritis plus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-3s Viral gastroenteritis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-35 Enteric fever (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-33.1 Urethritis basic (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-2P.3 Respiratory pathogens 33 (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-28 Bacterial meningitis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-23 EPA (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-2+.1 Respiratory pathogens 21 plus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-2 Respiratory pathogens 21 (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-14.1 Bacterial gastroenteritis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-13 Viral meningitis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTlyo-10.2 Fever and rash (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-CC.2-Bulk Light Cycler 480 colour compensation (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-90 HPV High Risk (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-9.1 Dermatophytes (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-84 Zika/Dengue/Chik (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-82 West Nile virus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-8.1 Cytomegalovirus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-78 Legionella (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-77 Zika virus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-75 Herpes simplex virus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-74 Epstein Barr virus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-73 Endogenous control (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-71 Ebola (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-70-100 Fast Track Mastermix (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-7 Vesicular rash (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-69 CCHFV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-68 RVFV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-67.1 Hepatitis E RNA (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-66 FTD SPn/Staph/MC/HI (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-65.2 HPIV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-62 Flu differentiation (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-60.4 Neuro 9 (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-6 Hepatitis C RNA (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-57 Internal Control EAV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-55.1 BKV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-53.1 Atypical CAP (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-52.1 STD9 (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-50.1 MERS-CoV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-5.1 Hepatitis B DNA2018-11-09
FAST TRACK DIAGNOSTICS
FTD-48.1 FLU/HRSV (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-46 Measles (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-44 Dengue differentiation (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-43 Dengue/Chik (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-42.1 Urethritis plus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-40 Malaria differentiation (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-39 FTD Malaria (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-38 Tropical fever Asia (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-37 Tropical fever Africa (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-36 Tropical fever core (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-34.1 Neonatal meningitis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-33.1 Urethritis basic (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-32.1 Neonatal sepsis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-31.1 Bordetella (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-30 Bacterial pneumonia_ HAP (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-3 Viral gastroenteritis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-2P.3 Respiratory pathogens 33 (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-29.1 Bacterial pneumonia_ CAP (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-28 Bacterial meningitis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-27 Pneumocystis jirovecii (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-24 C. difficile (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-23-EPA (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-21.1 FLU (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-20.1 Stool parasites (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-2+.1 Respiratory pathogens 21 plus (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-2 Respiratory pathogens 21 (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-19 Genital ulcer (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-17 Gonorrhoea confirmation (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-16 Mumps (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-15.1 Eye (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-14.1 Bacterial gastroenteritis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-13 Viral meningitis (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-12.1 Vaginal swab (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-10.2 Fever and rash (RUO)2018-11-09
FAST TRACK DIAGNOSTICS
FTD-1.1 ACE (RUO)2018-11-09

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