Multiple-viruses IVDs

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Revvity Pty Ltd

Clasă:

Class 3

Produs de:

Suzhou Sym-Bio Lifescience Co Ltd No 115 North Tai Ping Road Taicang Economic Development Zone, Jiangsu Province, 215400 China

Zonă Terapeutică:

CT702 - Multiple-viruses IVDs

Indicații terapeutice:

The PKamp Respiratory SARS-CoV-2 RT-PCR Panel assay is a real-time RT-PCR multiplexed test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A viruses, influenza B viruses and respiratory syncytial virus (RSV) or simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A viruses and influenza B viruses or detection of SARS-CoV-2 RNA only in upper respiratory specimens (nasopharyngeal, oropharyngeal and nasal swabs) collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider.

Statutul autorizaţiei:

A

Data de autorizare:

2020-11-26