115 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
FDA FEI Number: 3003268355
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Lyme ELISA (IgG/IgM)
FDA registration
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·1 product·🇩🇪 Germany
Anti-Borrelia burgdorferi US WESTERNBLOT (IgG)
FDA registration
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·1 product·🇩🇪 Germany
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
FDA registration
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·1 product·🇩🇪 Germany
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
LYME STAT TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
FDA 510(k)
FDA Class 2
·Microbiology
LYME IGM MICROASSAY
FDA 510(k)
FDA Class 2
·Microbiology
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
iDart Lyme IgM ImmunoBlot Kit
FDA 510(k)
FDA Class 2
·Microbiology
LYME DISEASE MICROASSAY
FDA 510(k)
FDA Class 2
·Microbiology
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
FDA 510(k)
FDA Class 2
·Microbiology
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Microbiology
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Anti-Borrelia burgdorferi US Westernblot (IgG)
FDA 510(k)
FDA Class 2
·Microbiology
QUANTA LITE LYME IGG ELISA
FDA 510(k)
FDA Class 2
·Microbiology
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
IMMUNODOT LYME TEST
FDA 510(k)
FDA Class 2
·Microbiology
Borrelia B31 ViraChip IgG Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
FDA 510(k)
FDA Class 2
·Microbiology