ARCHITECT Syphilis TP - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Abbott Australasia Pty Ltd Diagnostic Division

Klass:

Class 4

Tillverkad av:

Abbott GmbH Max Planck Ring 2, WIESBADEN, 65205 Germany

Terapiområde:

59861 - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Terapeutiska indikationer:

A chemiluminescent microparticle immunoassay for the detection of antibodies to treponema pallidum (syphilis) The ARCHITECT Syphilis TP assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of antibodies to Treponema pallidum (TP) in human serum and plasma, including specimens collected post-mortem (non-heart-beating) on the ARCHITECT analyser. Performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heart beating) that have been collected up to 24 hours after death.

Bemyndigande status:

A

Tillstånd datum:

2014-04-15