Singapore HSA registration DE0501600
Cepheid Xpert HCV Viral Load
Singapore·CLASS D IVD·Cepheid AB·Registered May 03, 2018Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0501600
- Registration Date
- May 03, 2018
- Change Notification Approval Date
- May 15, 2025
- Retention Due Date
- May 02, 2026
Product description
The HCV VL Assay, performed on GeneXpert® Instrument Systems, is designed for the rapid quantitation of Hepatitis C Virus (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. The test utilizes automated reverse transcriptase polymerase chain reaction (RT-PCR) using fluorescence to detect the RNA of interest for the quantitation of HCV. The HCV VL Assay quantifies HCV genotypes 1–6 over the range of 10 to 100,000,000 IU/mL.The HCV VL Assay is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy. The test measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and nonsustained virological responses to HCV therapy. Results from the HCV VL Assay may also be used to confirm HCV infection in anti-HCV positive individuals. The assay is not intended to be used as a donor screening test for HCV.
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 HCV Viral Load GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert GeneXpert
- Model Identifier(s)
- GXHCV-VL-CE-10 GXI-1-D GXI-1-L GXII-1-D GXII-1-L GXII-2-D GXII-2-L GXIV-1-D GXIV-1-L GXIV-2-D GXIV-2-L GXIV-3-D GXIV-3-L GXIV-4-D GXIV-4-L GXXVI-12-D GXXVI-12-L GXXVI-16-D GXXVI-16-L GXXVI-4-D GXXVI-4-L GXXVI-8-D GXXVI-8-L INFINITY48-16 INFINITY48-24 INFINITY48-32 INFINITY48-40 INFINITY48-48 INFINITY80-16 INFINITY80-24 INFINITY80-32 INFINITY80-40 INFINITY80-48 INFINITY80-56 INFINITY80-64 INFINITY80-80
About this record
Access comprehensive regulatory information for Cepheid Xpert HCV Viral Load 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 DE0501600 and owned by Cepheid AB. The device was registered on May 03, 2018.
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 D IVD