Singapore HSA registration DE0501954
BioFire Diagnostics FilmArray Instruments
Singapore·CLASS C IVD·BioFire Diagnostics, LLC·Registered July 27, 2018Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0501954
- Registration Date
- July 27, 2018
- Change Notification Approval Date
- September 06, 2024
- Retention Due Date
- July 26, 2025
Product description
The FilmArray instrument is an automated in vitro diagnostic device intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical samples. The instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The FilmArray software automatically determines the results and provides a test report.
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 2.0 Instrument FilmArray 2.0 Instrument FilmArray Torch Duplex FilmArray Torch System Base FilmArray Torch System Base (Rebuilt) FilmArray Torch Module FilmArray Torch Module (Rebuilt)
- Model Identifier(s)
- FLM2-ASY-0001 FLM2-ASY-0001-W HTFA-ASY-0102 HTFA-ASY-0104 HTFA-ASY-0104 (HTFA-ASY-0001-W) HTFA-SUB-0103 HTFA-SUB-0103 (HTFA-ASY-0003-W)
About this record
Access comprehensive regulatory information for BioFire Diagnostics FilmArray Instruments 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 DE0501954 and owned by BioFire Diagnostics, LLC. The device was registered on July 27, 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