Singapore HSA registration DE0502362
BioFire Diagnostics FilmArray RP2/RP2 Plus
Singapore·CLASS C IVD·BioFire Diagnostics, LLC·Registered November 21, 2018Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0502362
- Registration Date
- November 21, 2018
- Change Notification Approval Date
- March 15, 2021
- Retention Due Date
- November 20, 2025
Product description
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.
Product Owner
- Short Name
- BioFire Diagnostics, LLC
- Address
- 515 Colorow Dr., Salt Lake city, Utah, 84108, UNITED STATES
Registrant
- Address
- 11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667
Importer
- Address
- 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model information
- Model Name(s)
- FilmArray Respiratory Panel 2, 30 pack FilmArray Respiratory Panel 2, 6 pack FilmArray Respiratory Panel 2 plus (RP2plus), 30 pack FilmArray Respiratory Panel 2 plus (RP2plus), 6 pack
- Model Identifier(s)
- RFIT-ASY-0129 RFIT-ASY-0130 RFIT-ASY-0136 RFIT-ASY-0137
About this record
Access comprehensive regulatory information for BioFire Diagnostics FilmArray RP2/RP2 Plus in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0502362 and owned by BioFire Diagnostics, LLC. The device was registered on November 21, 2018.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD