Singapore HSA registration DE0507868
Cepheid Xpert MTB/XDR
Singapore·CLASS C IVD·Cepheid AB·Registered March 09, 2023Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0507868
- Registration Date
- March 09, 2023
- Change Notification Approval Date
- May 15, 2025
- Retention Due Date
- March 08, 2026
Product description
The Xpert MTB/XDR test, performed on the GeneXpert Instrument Systems, is a qualitative, nested real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of extensively drug resistant (XDR) Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples, concentrated sediments prepared from sputum, or BD™ Mycobacterial Growth Indicator Tube (MGIT™) culture. In specimens where MTB is detected, the Xpert MTB/XDR test can also detect isoniazid (INH) resistance associated mutations in the katG and fabG1 genes, oxyR-ahpC intergenic region and inhA promoter; ethionamide (ETH) resistance associated with inhA promoter mutations only; fluoroquinolone (FLQ) resistance associated mutations in the gyrA and gyrB quinolone resistance determining regions (QRDR); and second line injectable drug (SLID) associated mutations in the rrs gene and the eis promoter region.
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)
- Assay Definition File (ADF) Xpert MTB/XDR
- Model Identifier(s)
- Assay Definition File (ADF) GXMTB/XDR-10
About this record
Access comprehensive regulatory information for Cepheid Xpert MTB/XDR 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 DE0507868 and owned by Cepheid AB. The device was registered on March 09, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD