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Singapore HSA registration DE0503530

Cepheid Xpert Xpress Flu/RSV

Singapore flagSingapore·CLASS C IVD·Cepheid·Registered August 30, 2019
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0503530
Registration Date
August 30, 2019
Change Notification Approval Date
May 14, 2025
Retention Due Date
August 29, 2025
Product description
The Cepheid Xpert Xpress Flu/RSV Assay, performed on the GeneXpert Instrument Systems, is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Xpress Flu/RSV Assay uses nasopharyngeal (NP) swab and nasal swab (NS) specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Xpress Flu/RSV Assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus infections in conjunction with clinical and epidemiological risk factors. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions
Product Owner
Name
Cepheid
Short Name
Cepheid
Address
904 Caribbean Drive, Sunnyvale, United States, CA 94089, UNITED STATES
Registrant
Name
Cepheid Singapore Pte. Ltd.
Address
138 MARKET STREET, CAPITAGREEN, #05-06, SINGAPORE 048946
Importer
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
Xpert Xpress Flu/RSV Xpert Xpress Flu/RSV
Model Identifier(s)
XPRSFLU/RSV-10 XPRSFLU/RSV-CE-10
About this record

Access comprehensive regulatory information for Cepheid Xpert Xpress Flu/RSV 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 DE0503530 and owned by Cepheid. The device was registered on August 30, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD