32 results
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45ms
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Sources: EU EUDAMED, US FDA
FilmArray Pneumonia Panel plus
FDA 510(k)
FDA Class 2
·Pathology
T2Biothreat® QCheck Negative Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70885113983·Negative quality control for T2Biothreat Panel
T2Biothreat® Reagent Trays
FDA UDI
T2 BIOSYSTEMS, INC.·M70880113943·The T2Biothreat Panel component that contains t...
T2Biothreat® Cartridge Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70890114000·The T2Biothreat Panel components used to load t...
FilmArray® Respiratory Panel 2 plus (RP2plus)
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020291·IVD reagent kit containing 30 tests
BioFire® Global Fever Special Pathogens Panel
FDA UDI
BIOFIRE DEFENSE, LLC·00851458005273·BioFire® Global Fever Special Pathogens Panel -...
T2Biothreat® QCheck Positive Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70885113963·Buffer based solution with containing non-patho...
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane
FDA UDI
BIOFIRE DEFENSE, LLC·00851458005280·BIOFIRE® SHIELD™ Control Kit for the BioFire Gl...
FilmArray® Respiratory Panel 2 plus (RP2plus)
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020307·IVD reagent kit containing 6 tests
Multiplex Nucleic Acid Detection System For Biothreat Agents
FDA classification
FDA Class 2
·Multiplex Nucleic Acid Detection System For Biothreat Agents
Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
FDA classification
FDA Class 2
·Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
FDA classification
FDA Class 2
·Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System