32 results
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42ms
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Sources: EU EUDAMED, US FDA
T2 Biothreat Panel
FDA registration
T2 BIOSYSTEMS, INC.·3 products·🇺🇸 United States
OraQuick Ebola Rapid Antigen Test
FDA 510(k)
FDA Class 2
·Microbiology
BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
FDA 510(k)
FDA Class 2
·Immunology
T2 Biothreat Panel
FDA 510(k)
FDA Class 2
·Immunology
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...
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...
Multiplex Nucleic Acid Detection System For Biothreat Agents
FDA classification
FDA Class 2
·Multiplex Nucleic Acid Detection System For Biothreat Agents
Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
FDA classification
FDA Class 2
·Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens