NAME AND INTENDED USE
The MONOLISA™ Anti-HBc IgM EIA is an enzyme immunoassay intended for use in the qualitative detection of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium EDTA, sodium citrate, ACD [acid citrate dex- trose], lithium heparin and sodium heparin). Assay results may be used with other HBV serological markers for the laboratory diag- nosis of HBV disease associated with HBV infection.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
Federal law restricts this device to sale by or on the order of a physician.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.
EIA test for the qualitative detection of IgM antibodies to hepatitis B core antigen (Anti-HBc IgM) in human serum and plasma. Color changes during protocol steps. Controls with color coded caps. Kit is for 192 tests.
Unlicensed for Sale in Canada
Non-homologué pour la vente au Canada.