Guardant Health Guardant360® CDx - HSA Registration DE0508140
Access comprehensive regulatory information for Guardant Health Guardant360® CDx 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 DE0508140 and owned by Guardant Health Inc. The device was registered on May 29, 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.
Guardant360® CDx is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of single nucleotide variants, insertions and deletions in 55 genes, copy number amplifications in two genes,and fusions in four genes. Guardant360 CDx utilizes circulating cell-free DNA from plasma of peripheral whole blood. The test is intended to be used as a companion diagnostic to identify non-small cell lung cancer patients who may benefit from treatment with TAGRISSO® (osimertinib) in accordance with the approved therapeutic product labeling. Additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm. The test is for use with patients previously diagnosed with cancer and in conjunction with other laboratory and clinical findings.