Singapore HSA registration DE0504214
Cepheid Xpert® HBV Viral Load
Singapore·CLASS C IVD·Cepheid AB·Registered March 11, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0504214
- Registration Date
- March 11, 2020
- Change Notification Approval Date
- May 15, 2025
- Retention Due Date
- March 10, 2026
Product description
The Cepheid Xpert HBV Viral Load (VL) assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals using the automated GeneXpert Systems. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. The test is not intended to be used as a donor screening test for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.
Product Owner
- Name
- Cepheid AB
- Short Name
- Cepheid AB
- Address
- Rontgenvagen 5, SE-171 54 Solna, SWEDEN
Registrant
- Address
- 138 MARKET STREET, CAPITAGREEN, #05-06, SINGAPORE 048946
Importer
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
- Model Name(s)
- Xpert HBV Viral Load Xpert HBV Viral Load Assay Definition File
- Model Identifier(s)
- GXHBV-VL-CE-10 Xpert HBV Viral Load Assay Definition File
About this record
Access comprehensive regulatory information for Cepheid Xpert® HBV Viral Load 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 DE0504214 and owned by Cepheid AB. The device was registered on March 11, 2020.
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