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

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Beszerezhető a:

Abbott Australasia Pty Ltd Diagnostic Division

Osztály:

Class 4

Gyártó:

Abbott GmbH Max Planck Ring 2, WIESBADEN, 65205 Germany

Terápiás terület:

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

Terápiás javallatok:

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.

Engedélyezési státusz:

A

Engedély dátuma:

2014-04-15