Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Elitechgroup). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The product ENTEROVIRUS ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used by healthcare professionals as quantitative nucleic acids reverse transcription and Real-Time PCR assay for the detection and quantification of the RNA of Human Enterovirus (A, B, C, D), extracted from clinical specimens.