Cytocell CKS1B/CDKN2C (P18) Amplification/ Deletion Probe - HSA Registration DE0510011
Access comprehensive regulatory information for Cytocell CKS1B/CDKN2C (P18) Amplification/ Deletion Probe 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 DE0510011 and owned by Cytocell Limited. The device was registered on November 06, 2024.
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 CytoCell® CKS1B/CDKN2C (P18) Amplification/Deletion Probe is a qualitative, non- automated, fluorescence in situ hybridisation (FISH) test used to detect chromosomal gains and deletions in the 1p32.3 and 1q21 regions on chromosome 1 in Carnoy’s solution (3:1 methanol/acetic acid) fixed haematologically- derived cell suspensions from patients with confirmed or suspected multiple myeloma (MM). This device is designed as an adjunct to other clinical and histopathological tests in recognised diagnostic and clinical care pathways, where knowledge of CKS1B or CDKN2C (P18) status would be important for clinical management.