Bacterial infectious disease IVDs

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Beszerezhető a:

Hologic (Australia & New Zealand) Pty Ltd

Osztály:

Class 2

Gyártó:

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

Terápiás terület:

CT353 - Bacterial infectious disease IVDs

Terápiás javallatok:

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.

Engedélyezési státusz:

A

Engedély dátuma:

2019-07-29