Singapore HSA registration DE0506342
Hologic Panther System
Singapore·CLASS C IVD·Hologic, Inc.·Registered November 03, 2021Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506342
- Registration Date
- November 03, 2021
- Change Notification Approval Date
- January 03, 2025
- Retention Due Date
- November 02, 2025
Product description
The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection and data reduction.
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 System, Continuous Fluid and Waste (Panther Plus) Panther System Continuous Access Kit with Assembled Waste Drawer MTU Expansion Kit Waste to Drain Module Track Ready Shuttle Module
- Model Identifier(s)
- 10108323 (PRD-05490) 9120900000 (303095) ASY-13103 ASY-13105 ASY-13106 ASY-13472
About this record
Access comprehensive regulatory information for Hologic Panther System 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 DE0506342 and owned by Hologic, Inc.. The device was registered on November 03, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD