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Hologic Panther System - HSA Registration DE0506342

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.

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CLASS C IVD
DE0506342
Hologic Panther System
HSA Registration Number: DE0506342
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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.

Device 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 Owner
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