115 results · 41ms · Sources: EU EUDAMED, US FDA

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