ELITechGroup VZV ELITe MGB kit

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SPD SCIENTIFIC PTE LTD

Class:

Class C IVD

Manufactured by:

ELITechGroup S.p.A.

Therapeutic area:

Microbiology

Therapeutic indications:

The «VZV ELITe MGB® Kit» product is an in vitro diagnostic medical device intended to be used by healthcare professionals as a qualitative nucleic acids amplification assay for the detection of the DNA of human herpetic Varicella - Zoster virus (VZV) in clinical samples. The assay was validated in association with ELITe InGenius® system starting form cerebrospinal fluid (CSF), whole blood collected in EDTA, and plasma collected in EDTA. The product is intended for use as an aid in the diagnosis of VZV infections alongside clinical data of the patient and other laboratory tests outcomes.

Product summary:

Models: VZV ELITe MGB® Kit - RTS035PLD, VZV– ELITe Positive Control - CTR035PLD

Authorization date:

2023-01-31