Cepheid Xpert® MTB/RIF Ultra - HSA Registration DE0501684
Access comprehensive regulatory information for Cepheid Xpert® MTB/RIF Ultra 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 DE0501684 and owned by Cepheid AB. The device was registered on May 31, 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.
The Xpert MTB/RIF Ultra Assay, performed on the GeneXpert Instrument Systems, is a semi-quantitative, nested real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples or concentrated sediments prepared from induced or expectorated sputum. In specimens where Mycobacterium tuberculosis complex is detected, the Xpert MTB/RIF Ultra Assay can also detect rifampin-resistance associated mutations of the rpoB gene. The Xpert MTB/RIF Ultra Assay is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy in the last 6 months. This test is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.