Captia Malaria EIA - Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA)

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Abbott Rapid Diagnostics Pty Ltd

Klasse:

Class 4

Produsert av:

Trinity Biotech USA 2823 Girts Road, JAMESTOWN, NEW YORK, 14701 United States Of America

Terapeutisk område:

52327 - Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA)

Indikasjoner:

Captia Malaria EIA uses four recombinant antigens in a sandwich test to produce a test that is both specific and sensitive. The antigens will detect P falciparum and P. vivax -specific IgG, IgM, and IgA, enabling the test to detect antibodies during all stages of infection. The assay can be used with both serum and plasma. This kit is intended for use by appropriately trained and qualified personnel for the qualitative and semi-quantitative detection of antibodies to Plasmodium falciparum (P. falciparum) and Plasmodium vivax (P. vivax), in human serum and plasma.

Autorisasjon status:

A

Autorisasjon dato:

2015-12-07