BioFire Diagnostics FilmArray Respiratory Panel Kit

Singapore - English - HSA (Health Sciences Authority)

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Available from:
BIOMERIEUX SINGAPORE PTE. LTD.
Class:
Class C IVD
Manufactured by:
BioFire Diagnostics, LLC
Therapeutic area:
Microbiology
Therapeutic indications:
FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with the FilmArray Instrument 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 RP: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Human Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions
Product summary:
Models: FilmArray Respiratory Panel (6 Pack Kit) - RFIT-ASY-0125, FilmArray Respiratory Panel (30 pack Kit) - RFIT-ASY-0124
Authorization number:
DE0016973
Authorization date:
2015-03-30

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