Enteroviruses 68-71 IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
28-05-2020
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Available from:
Biomerieux Australia Pty Ltd
Class:
Class 3
Manufactured by:
Biomerieux SA 376 Chemin de l'Orme, Marcy, L Etoile, 69280 France
Therapeutic area:
CT716 - Enteroviruses 68-71 IVDs
Therapeutic indications:
The ENTEROVIRUS R-GENE? kit rapidly detects the enterovirus genome using the real-time PCR technique on CSF, respiratory samples (throat swabs and nasopharyngeal secretions), stool, and cell cultures. Combined with other biological investigation methods (medical imaging, biochemical and immunological analysis, etc,the results obtained with the ENTEROVIRUS R-GENE? kit can be used to diagnose viral infections.
Authorization status:
A
Authorization date:
2020-03-27
