ARCHITECT Syphilis TP - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
23-11-2017
अनुरोध भेजा।
थमां उपलब्ध:
Abbott Australasia Pty Ltd Diagnostic Division
वर्ग:
Class 4
द्वारा बनाया गया:
Abbott GmbH Max Planck Ring 2, WIESBADEN, 65205 Germany
चिकित्सीय क्षेत्र:
59861 - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
चिकित्सीय संकेत:
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.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2014-04-15
