Singapore HSA registration DE0506517
Hologic Panther Fusion™ MRSA
Singapore·CLASS C IVD·Hologic, Inc.·Registered December 24, 2021Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506517
- Registration Date
- December 24, 2021
- Change Notification Approval Date
- January 03, 2025
- Retention Due Date
- December 23, 2025
Product description
The Panther Fusion™ MRSA assay is an automated in vitro diagnostic test that uses Invader Plus™ chemistry for the qualitative detection and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swab specimens. This assay is intended for use on the Panther Fusion system to aid in the prevention and control of MRSA/SA infections in healthcare settings.
Product Owner
- Name
- Hologic, Inc.
- Short Name
- Hologic, Inc.
- Address
- 10210 Genetic Center Drive, San Diego, California 92121, UNITED STATES
Registrant
- Address
- 36 ROBINSON ROAD, CITY HOUSE, #10-01-05, SINGAPORE 068877
Importer
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
- Model Name(s)
- Panther Fusion Elution Buffer Panther Fusion Oil Panther Fusion Internal Control-X Panther Fusion Extraction Reagent-X Panther Fusion MRSA Reagent Cartridges Panther Fusion Reconstitution Buffer II Panther Fusion MRSA Controls Kit
- Model Identifier(s)
- PRD-04334 PRD-04335 PRD-04476 PRD-04477 PRD-04803 PRD-04804 PRD-04805
About this record
Access comprehensive regulatory information for Hologic Panther Fusion™ MRSA 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 DE0506517 and owned by Hologic, Inc.. The device was registered on December 24, 2021.
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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