BioFire Diagnostics Respiratory Panel 2.1 (RP2.1) - HSA Registration DE0507420
Access comprehensive regulatory information for BioFire Diagnostics Respiratory Panel 2.1 (RP2.1) in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0507420 and owned by BioFire Diagnostics, LLC. The device was registered on October 28, 2022.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The BioFire Respiratory Panel 2.1 (RP2.1) is a PCR- based multiplexed nucleic acid test intended for use with the BioFire FilmArray® 2.0 or BioFire FilmArray® Torch Systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections, including COVID-19. The following organism types and subtypes are identified using the BioFire RP2.1:Adenovirus, Coronavirus 229E, Coronavirus HKU1,Coronavirus NL63, Coronavirus OC43, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS- CoV-2), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, including subtypes H1, H1-2009, and H3, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumonia.