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Cepheid Xpert Xpress SARS-CoV-2 - HSA Registration DE0508194

Access comprehensive regulatory information for Cepheid Xpert Xpress SARS-CoV-2 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 DE0508194 and owned by Cepheid. The device was registered on June 14, 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.

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CLASS D IVD
DE0508194
Cepheid Xpert Xpress SARS-CoV-2
HSA Registration Number: DE0508194
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Product Description

The Xpert Xpress SARS-CoV-2 test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and nasal swab collected from individuals who are suspected of COVID-19 infection.

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0508194
Registration Date
June 14, 2023
Change Notification Approval Date
March 24, 2025
Retention Due Date
June 13, 2025
Product Owner
Short Name
Cepheid
Address
904 Caribbean Drive Sunnyvale, 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)
Assay Definition File (ADF) Xpertยฎ Xpress SARS-CoV-2
Model Identifier(s)
Assay Definition File (ADF) XPRSARS-COV2-10