Bacterial infectious disease IVDs

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

제공처:

Hologic (Australia & New Zealand) Pty Ltd

수업:

Class 2

Manufactured by:

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

치료 영역:

CT353 - Bacterial infectious disease IVDs

치료 징후:

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.

승인 상태:

A

승인 날짜:

2019-07-29