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Singapore HSA registration DE0508119

Hologic Panther Fusion® Flu A/B/RSV Assay

Singapore flagSingapore·CLASS C IVD·Hologic, Inc.·Registered May 24, 2023
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0508119
Registration Date
May 24, 2023
Change Notification Approval Date
January 03, 2025
Retention Due Date
May 23, 2025
Product description
The Panther Fusion® Flu A/B/RSV Assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. This assay is intended to aid in the differential diagnosis of influenza A virus, influenza B virus and RSV infections in humans and is not intended to detect influenza C virus infections. Negative results do not preclude influenza A virus, influenza B virus or RSV infections and should not be used as the sole basis for treatment or other management decisions. This assay is designed for use on the Panther Fusion system.
Product Owner
Name
Hologic, Inc.
Short Name
Hologic, Inc.
Address
10210 Genetic Center Drive, San Diego, California 92121, UNITED STATES
Registrant
Name
HOLOGIC SINGAPORE PTE. LTD.
Address
36 ROBINSON ROAD, CITY HOUSE, #10-01-05, SINGAPORE 068877
Importer
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
Model Name(s)
Panther Fusion® Flu A/B/RSV Assay Cartridges Panther Fusion Extraction Reagent-S Panther Fusion® Internal Control-S Panther Fusion® Reconstitution Buffer I Panther Fusion® Elution Buffer Panther Fusion® Oil Panther Fusion Flu A/B/RSV Assay Controls
Model Identifier(s)
PRD-04328 PRD-04331 PRD-04332 PRD-04333 PRD-04334 PRD-04335 PRD-04336
About this record

Access comprehensive regulatory information for Hologic Panther Fusion® Flu A/B/RSV Assay 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 DE0508119 and owned by Hologic, Inc.. The device was registered on May 24, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD