74 results · 43ms · Sources: EU EUDAMED, US FDA

T2Candida 1.1 Panel

FDA registration
T2 BIOSYSTEMS, INC.·1 product·🇺🇸 United States

CandID

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

T2Candida 1.1 Panel

FDA registration
T2 BIOSYSTEMS, INC.·1 product·🇺🇸 United States

PII / Candida species nucleic acid detection system

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

T2Dx® QCheck Negative Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70885083760·Negative Control

T2Candida® Reagent Trays

FDA UDI
T2 BIOSYSTEMS, INC.·M70880016893·The T2Candida component that contains the refri...

T2Dx® QCheck Negative Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70885083763·Negative Control

T2Bacteria® Cartridge Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70890080710·The T2Bacteria Cartridge components used to loa...

T2Candida® 1.1 Cartridge Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70890078170·The T2Candida 1.1 Cartridge components used to ...

T2Candida® QCheck Positive Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70885083750·Positive APG Control, Positive TPK Control

T2Candida® External Controls

FDA UDI
T2 BIOSYSTEMS, INC.·M70885049190·IVD Positive APG, Positive TPK, Negative EDTA Kit

T2Bacteria® Reagent Trays

FDA UDI
T2 BIOSYSTEMS, INC.·M70880073423·The T2Bacteria component that contains the refr...

T2Candida® Cartridge Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70890017940·The T2Candida components used to load the patie...

T2Bacteria® Reagent Trays

FDA UDI
T2 BIOSYSTEMS, INC.·M70880080723·The T2Bacteria component that contains the refr...

T2Bacteria® QCheck Negative Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70885080743·Negative Control for T2Bacteria Panel

T2Bacteria® QCheck Positive Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70885071910·Positive SK Control, Positive EPE Control

T2Bacteria® QCheck Positive Kit

FDA UDI
T2 BIOSYSTEMS, INC.·M70885080730·Positive ASK Control, Positive EPE Control

T2Bacteria Panel

FDA registration
T2 BIOSYSTEMS, INC.·2 products·🇺🇸 United States

NSU / Instrumentation for clinical multiplex test systems QBX / Direct blood bacterial nucleic acid detection system

FDA registration
MONOCENT INC.·2 products·🇺🇸 United States

T2Dx Instrument

FDA registration
T2 BIOSYSTEMS, INC.·2 products·🇺🇸 United States