ELITechGroup CMV ELITe MGB Kit

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Tillgänglig från:

SPD SCIENTIFIC PTE LTD

Klass:

Class C IVD

Tillverkad av:

ELITechGroup S.p.A

Terapiområde:

Microbiology

Terapeutiska indikationer:

The «CMV ELITe MGB® Kit» product is an in vitro diagnostic medical device intended to be used by healthcare professionals as a qualitative nucleic acids Real-Time PCR assay for the detection of the DNA of Human Cytomegalovirus (CMV) extracted from clinical specimens. The assay is validated in association with the «ELITe InGenius» instrument, automated and integrated system for extraction, Real-Time PCR and results interpretation, using human specimens of whole blood collected in EDTA (WB), plasma collected in EDTA (PL). The product is intended for use as an aid in the diagnosis of CMV infections. The results must be interpreted in combination with all relevant clinical observations and laboratory outcomes.

Produktsammanfattning:

Models: CMV ELITe MGB® Kit - RTK015PLD, CMV – ELITe Positive Control - CTR015PLD

Tillstånd datum:

2023-04-27