Bacterial infectious disease IVDs

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Dostopno od:

Hologic (Australia & New Zealand) Pty Ltd

Razred:

Class 2

Izdeluje:

Hologic Inc 10210 Genetic Center Drive, San Diego, CA, 92121 United States Of America

Terapevtsko območje:

CT353 - Bacterial infectious disease IVDs

Terapevtske indikacije:

The Aptima? BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV on the automated Panther? system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.

Status dovoljenje:

A

Datum dovoljenje:

2019-07-29