83 results
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41ms
·
Sources: EU EUDAMED, US FDA
ID-FISH Plasmodium faliciparum and P. vivax Combo Test Kit
FDA registration
ID-FISH TECHNOLOGY, INC·1 product·🇺🇸 United States
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
FDA classification
FDA Class 2
·Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
MOL2160 Simplexa HSV 1 & 2 Positive Control Pack
FDA registration
DiaSorin Molecular LLC·1 product·🇺🇸 United States
US IVD HCCA
FDA registration
Bruker Daltonics·1 product·🇩🇪 Germany
VITEK MS
FDA registration
BIOMERIEUX SA·1 product·🇫🇷 France
VITEK® MS
FDA registration
BIOMERIEUX SA·1 product·🇫🇷 France
US IVD HCCA
FDA registration
BRUKER SCIENTIFIC LLC·1 product·🇺🇸 United States
MALDI Biotyper MBT Smart CA System
FDA registration
BRUKER SCIENTIFIC LLC·1 product·🇺🇸 United States
MALDI Biotyper MBT Smart CA System
FDA registration
Bruker Daltonics·1 product·🇩🇪 Germany
VitekMS
FDA registration
KRATOS ANALYTICAL LTD.·1 product·🇬🇧 United Kingdom
MALDI Biotyper MBT smart CA System
FDA registration
Bruker Daltonics·1 product·🇩🇪 Germany
US IVD HCCA
FDA registration
InVivo BioTech Services GmbH·1 product·🇩🇪 Germany
MALDI Biotyper MBT smart CA System
FDA registration
BRUKER SCIENTIFIC LLC·1 product·🇺🇸 United States
HERPES SIMPLEX VIRUS (HSV) 1.2 Panel PCR
FDA registration
MONOCENT INC.·1 product·🇺🇸 United States
ePlex
FDA UDI
GENMARK DIAGNOSTICS, INC.·00857167005313·ePlex Blood Culture Identification Gram Negativ...
ePlex
FDA UDI
GENMARK DIAGNOSTICS, INC.·00857167005320·ePlex Blood Culture Identification Gram Positiv...
BioFire® Blood Culture Identification 2 (BCID2) Panel
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020338·IVD reagent kit containing 30 tests.
ePlex
FDA UDI
GENMARK DIAGNOSTICS, INC.·00857167005337·ePlex Blood Culture Identification Gram Positiv...
ePlex
FDA UDI
GENMARK DIAGNOSTICS, INC.·00857167005283·ePlex Blood Culture Identification Fungal Patho...