Cepheid Xpert HBV Viral Load

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Beschikbaar vanaf:

SPD SCIENTIFIC PTE LTD

klasse:

Class C IVD

Geproduceerd door:

Cepheid AB

Therapeutisch gebied:

Microbiology

therapeutische indicaties:

The Cepheid Xpert HBV Viral Load (VL) assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals using the automated GeneXpert Systems. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. The test is not intended to be used as a donor screening test for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.

Product samenvatting:

Models: Xpert HBV Viral Load - GXHBV-VL-CE-10

Autorisatie datum:

2020-03-11