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

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Διαθέσιμο από:

Abbott Australasia Pty Ltd Diagnostic Division

Kατηγορία:

Class 4

Κατασκευάζεται από:

Abbott GmbH Max Planck Ring 2, WIESBADEN, 65205 Germany

Θεραπευτική περιοχή:

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

Θεραπευτικές ενδείξεις:

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.

Καθεστώς αδειοδότησης:

A

Ημερομηνία της άδειας:

2014-04-15