35 results · 42ms · Sources: EU EUDAMED, US FDA

BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

FDA registration
BioFire Defense, LLC·3 products·🇺🇸 United States

T2 Biothreat Panel

FDA registration
T2 BIOSYSTEMS, INC.·3 products·🇺🇸 United States

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

NA

FDA UDI
Institut Straumann AG·07630031744708·Sugical Handle, for TorcFit™ Implant Driver, st...

OraQuick Ebola Rapid Antigen Test

FDA registration
ORASURE TECHNOLOGIES INC.·1 product·🇺🇸 United States

BioFire FilmArray Pneumonia plus Panel

FDA registration
BioFire Diagnostics, LLC·1 product·🇺🇸 United States

OraQuick Ebola Rapid Antigen Test

FDA registration
ORASURE TECHNOLOGIES, INC.·1 product·🇺🇸 United States

OraQuick Ebola Rapid Antigen Test

FDA registration
ORASURE TECHNOLOGIES, INC.·1 product·🇺🇸 United States

MERS-CoV PCR

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

BIOFIRE FILMARRAY Pneumonia Panel plus

FDA registration
BioFire Diagnostics, LLC·1 product·🇺🇸 United States

OraQuick Ebola Rapid Antigen Test

FDA registration
ORASURE TECHNOLOGIES, INC.·1 product·🇺🇸 United States

NA

FDA UDI
OPHTHALMED LLC·M735A5676001·