Cepheid Xpert CT/NG - HSA Registration DE0013598
Access comprehensive regulatory information for Cepheid Xpert CT/NG 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 DE0013598 and owned by Cepheid. The device was registered on August 13, 2013.
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.
The Xpert® CT/NG Assay, performed on the GeneXpert Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting). The Cepheid® Xpert® CT/NG Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve and transport patient CT and NG DNA in endocervical and vaginal specimens prior to analysis with the Cepheid Xpert CT/NG Assay. The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport CT and NG DNA in first-catch male and female urine specimens prior to analysis with the Cepheid Xpert CT/NG Assay.