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Singapore HSA registration DE0508701

BioFire Diagnostics BioFire Joint Infection Panel

Singapore flagSingapore·CLASS C·BioFire Diagnostics, LLC·Registered November 29, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0508701
Registration Date
November 29, 2023
Change Notification Approval Date
March 28, 2024
Retention Due Date
November 28, 2025
Product description
BioFire Joint Infection Panel is a multiplexed nucleic-acid-based intended for simultaneous qualitative detection, identification of multiple bacterial, yeast nucleic acids and select antimicrobial resistance genes from synovial fluid obtained from individuals suspected to have a joint infection. The BioFire JI Panel is indicated as an aid in the diagnosis of specific agents of joint infection and results should be used in conjunction with other clinical and laboratory findings. The BioFire JI Panel is not intended to monitor treatment for joint infections.
Product Owner
Name
BioFire Diagnostics, LLC
Short Name
BioFire Diagnostics, LLC
Address
515 Colorow Dr., Salt Lake city, Utah, 84108, UNITED STATES
Registrant
Name
BIOMERIEUX SINGAPORE PTE. LTD.
Address
11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667
Importer
Name
BIOMERIEUX SINGAPORE PTE. LTD.
Address
11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model information
Model Name(s)
BioFire JI Panel software BioFire Joint Infection (JI) Panel
Model Identifier(s)
BioFire JI Panel software RFIT-ASY-0138
About this record

Access comprehensive regulatory information for BioFire Diagnostics BioFire Joint Infection Panel in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508701 and owned by BioFire Diagnostics, LLC. The device was registered on November 29, 2023.

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.

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