BioFire Diagnostics, LLC
113 devices
Public registrations
9 cert. types · 113 public registrations
- MFDS
- FDA 510(k)
- FDA De Novo
- CE-MDR
- NMPA
- Health Canada
- HSA
- ANVISA
- +1 more
- Main field
- Other
- Main manufacturing country
- US
Aggregated from registration data published by national regulators. It is not a count of currently valid certifications and may include expired or withdrawn records. Some registrations do not state a manufacturing country.
Products
- BioFire® Diagnostics SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelIPLHSA
- 고위험성감염체유전자검사시약IPLMFDS
- 실시간유전자증폭장치In Vitro DiagnosticsMFDS
- FilmArray® Meningitis/Encephalitis (ME) Panel (30 pack)In Vitro DiagnosticsMHRA
- FilmArray® Gastrointestinal (GI) Panel, (6 pack)In Vitro DiagnosticsMHRA
- FilmArray® Torch System BaseIn Vitro DiagnosticsMHRA
- BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniOtherFDA 510(k)
- BIOFIRE® Blood Culture Identification 2 (BCID2) Panel (30 pack)In Vitro DiagnosticsMHRA
- BIOFIRE® Joint Infection (JI) Panel (30 pack)In Vitro DiagnosticsMHRA
- FilmArray® Pneumonia Panel plus, 6 TestsIn Vitro DiagnosticsMHRA
- BIOFIRE® FILMARRAY® Tropical Fever (TF) PanelIn Vitro DiagnosticsMHRA
- BioFire® Blood Culture Identification 2 (BCID2) PanelOtherFDA 510(k)
- BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidOtherFDA 510(k)
- BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidOtherFDA 510(k)
- BIOFIRE® FILMARRAY® Tropical Fever PanelOtherFDA 510(k)
- BioFire® Joint Infection (JI) PanelOtherFDA 510(k)
- FilmArray® Meningitis/Encephalitis (ME) Panel (6 pack)In Vitro DiagnosticsMHRA
- BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidOtherFDA 510(k)
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))OtherFDA 510(k)
- BIOFIRE® SPOTFIRE® ModuleIn Vitro DiagnosticsMHRA
- BIOFIRE FILMARRAY Gastrointestinal (GI) PanelOtherFDA 510(k)
- FILMARRAY PNEUMONIA PANEL PLUSOtherHealth Canada
- BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniOtherFDA 510(k)
- BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniOtherFDA 510(k)
- BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelOtherFDA 510(k)
- BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelOtherFDA 510(k)
- 고위험성감염체유전자검사시약IPLMFDS
- BioFire® SpotFire®OtherANVISA
- BIOFIRE JOINT INFECTION (JI) PANELOtherHealth Canada
- BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniOtherFDA 510(k)
- BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniOtherFDA 510(k)
- BIOFIRE ® SPOTFIRE ® Control StationOtherFDA 510(k)
- BIOFIRE ® SPOTFIRE ® Control StationOtherFDA 510(k)
- BIOFIRE ® SPOTFIRE ® ModuleOtherFDA 510(k)
- BIOFIRE ® SPOTFIRE ® ModuleOtherFDA 510(k)
- BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelOtherFDA 510(k)
- BIOFIRE FILMARRAY Gastrointestinal (GI) PanelOtherFDA 510(k)
- 고위험성감염체유전자검사시약IPLMFDS
- FilmArray Pneumonia Panel plusOtherFDA 510(k)
- BioFire Joint Infection (JI) PanelIn Vitro DiagnosticsMHRA
- BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANELOtherHealth Canada
- BioFire Joint Infection (JI) PanelOtherFDA 510(k)
- BioFire Joint Infection (JI) PanelOtherFDA De Novo
- 全自动医用PCR分析系统OtherNMPA
- FilmArray Pneumonia PanelOtherFDA 510(k)
- 고위험성감염체유전자검사시약IPLMFDS
- BioFire® Blood Culture Identification 2 (BCID2) PaneIn Vitro DiagnosticsMHRA
- BioFire Respiratory Panel 2.1 (RP2.1)OtherFDA De Novo
- BioFire Respiratory Panel 2.1 (RP2.1)OtherFDA 510(k)
- BioFire Blood Culture Identification 2 (BCID2) PanelOtherFDA 510(k)
- 고위험성감염체유전자검사시약IPLMFDS
- 실시간유전자증폭장치OtherMFDS
- FILMARRAY TORCH DUPLEXOtherHealth Canada
- FilmArray Pneumonia Panel plusOtherFDA 510(k)
- FilmArray Pneumonia PanelOtherFDA 510(k)
- Biofire FilmArray TorchOtherANVISA
- FilmArray Blood Culture Identification (BCID) PanelOtherFDA 510(k)
- Biofire FilmArray 2.0OtherANVISA
- FilmArray Respiratory Panel 2 plus (RP2plus)OtherFDA De Novo
- FilmArray Respiratory Panel 2 plus (RP2plus)OtherFDA 510(k)
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Companies with similar names
Other companies whose names are written similarly. They may be the same company recorded differently, or entirely unrelated.
- Biofire Diagnostics2 devicesOtherUS
- Biofire Diagnostics, LLC (Biomerieux)2 devicesOtherUS
- Biofire Diagnostics, Inc.5 devicesOther
- Diagnostics Direct, LLC1 devicesOther
- O.N. Diagnostics, LLC1 devicesDiagnostic Imaging
- Bio-Diagnostics Ltd41 devicesIn Vitro DiagnosticsGB
These companies have similar names. This does not mean they are the same legal entity. We do not merge companies automatically, so check each company's registration details to judge any relationship.