Singapore HSA registration DE0507420
BioFire Diagnostics Respiratory Panel 2.1 (RP2.1)
Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0507420
- Registration Date
- October 28, 2022
- Change Notification Approval Date
- July 29, 2024
- Retention Due Date
- October 27, 2025
Product description
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.
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
Model information
- Model Name(s)
- Biofire Respiratory Panel 2.1 (RP2.1), 30 pack BioFire RP2.1 Pouch Module Software
- Model Identifier(s)
- 423742 BioFire RP2.1 Pouch Module Software
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD