Singapur - engleski - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the product hhv6 elite mgb® kit is an in vitro diagnostic medical device intended to be used by healthcare professionals as part of a nucleic acids amplification assay for the detection and quantification of the genomic dna of human herpesvirus 6 (hhv6), variant a and b, extracted from clinical specimens. the assay is validated in association with the elite ingenius®, automated and integrated systems for extraction, real-time pcr and results interpretation, using human specimens of whole blood collected in edta. the product is intended for use as an aid in the diagnosis and monitoring of hhv6 infections in patients suspected of having an hhv6 infection or undergoing monitoring of hhv6 infection. the results must be interpreted in combination with all relevant clinical observations and laboratory outcomes.