LIAISON XL MUREX anti-HBs - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Offentlige vurderingsrapport
(PAR)
28-05-2019
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Tilgængelig fra:
DiaSorin Australia Pty Ltd
Klasse:
Class 4
Fremstillet af:
DiaSorin Italia SpA Via Crescentino snc, Saluggia VC, 13040 Italy
Terapeutisk område:
48316 - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Terapeutiske indikationer:
The LIAISON? XL MUREX Anti-HBs assay uses chemiluminescence immunoassay (CLIA) technology for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human serum or plasma samples. The test has to be performed on the LIAISON? Analyzer family. IVDs for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs).
Autorisation status:
A
Autorisation dato:
2018-03-29
