BioFire Diagnostics FilmArray RP2RP2 Plus

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

から入手可能:

BIOMERIEUX SINGAPORE PTE. LTD.

クラス:

Class C IVD

製:

BioFire Diagnostics, LLC

治療領域:

Microbiology

適応症:

The FilmArray RP2/RP2 plus are multiplexed nucleic acid tests intended for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the FilmArray RP2/RP2plus: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, including subtypes H1, H1-2009, and H3, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV)- only for RP2plus, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus, Bordetella parapertussis (IS1001), Bordetella pertussis (ptxP), Chlamydia pneumoniae, Mycoplasma pneumonia.

製品概要:

Models: FilmArray Respiratory Panel 2 plus (RP2plus), 6 pack - RFIT-ASY-0137, FilmArray Respiratory Panel 2 plus (RP2plus), 30 pack - RFIT-ASY-0136, FilmArray Respiratory Panel 2, 30 pack - RFIT-ASY-0129, FilmArray Respiratory Panel 2, 6 pack - RFIT-ASY-0130

承認日:

2018-11-21