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Cepheid GeneXpert Systems - HSA Registration DE0503245

Access comprehensive regulatory information for Cepheid GeneXpert Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0503245 and owned by Cepheid. The device was registered on June 18, 2019.

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 D IVD
DE0503245
Cepheid GeneXpert Systems
HSA Registration Number: DE0503245
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Product Description

The GeneXpert Dx system is an in vitro diagnostic device intended for use with the Cepheid Xpert® test kits. The GeneXpert Dx system automates and integrates sample preparation, nucleic acid amplification, and detection of the target sequence in simple or complex samples using real- time Polymerase Chain Reaction (PCR). The system is designed for hands-off processing of patient samples (specimens) and provides both summarized and detailed test results data in tabular and graphic formats.

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0503245
Registration Date
June 18, 2019
Change Notification Approval Date
March 24, 2025
Retention Due Date
June 17, 2025
Product Owner
Short Name
Cepheid
Address
904 Caribbean Drive, Sunnyvale, United States, CA 94089, UNITED STATES
Registrant
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model Information
Model Name(s)
GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GeneXpert GeneXpert Dx System GX-XVI-8 to GX-XVI-12 GeneXpert GeneXpert GeneXpert Software Version 6.5 GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert Infinity-80  GeneXpert Infinity-80  GeneXpert Infinity-80  GeneXpert Infinity-80  GeneXpert Infinity-80  GeneXpert Infinity-80  GeneXpert Infinity-80  GeneXpert Infinity-80  GeneXpert Infinity-80  Xpertise Software 6.8
Model Identifier(s)
GXII-1-D GXII-1-D-10C GXII-1-L GXII-1-L-10C GXII-2-D GXII-2-D-10C GXII-2-L GXII-2-L-10C GXIV-1-D GXIV-1-D-10C GXIV-1-L GXIV-1-L-10C GXIV-2-D GXIV-2-D-10C GXIV-2-L GXIV-2-L-10C GXIV-3-D GXIV-3-D-10C GXIV-3-L GXIV-3-L-10C GXIV-4-D GXIV-4-D-10C GXIV-4-L GXIV-4-L-10C GXSINGLEADD GXXVI-12-D GXXVI-12-D-10C GXXVI-12-L GXXVI-12-L-10C GXXVI-16-D GXXVI-16-D-10C GXXVI-16-L GXXVI-16-L-10C GXXVI-4-D GXXVI-4-D-10C GXXVI-4-L GXXVI-4-L-10C GXXVI-8-D GXXVI-8-D-10C GXXVI-8-L GXXVI-8-L-10C GXXVI12ADD GXXVI4ADD GXXVI8ADD GeneXpert Software Version 6.5 INFINITY48-16 INFINITY48-24 INFINITY48-32 INFINITY48-40 INFINITY48-48 INFINITY80-16 INFINITY80-24 INFINITY80-32 INFINITY80-40 INFINITY80-48 INFINITY80-56 INFINITY80-64 INFINITY80-72 INFINITY80-80 Xpertise Software 6.8