Singapore HSA registration DE0510011
Cytocell CKS1B/CDKN2C (P18) Amplification/ Deletion Probe
Singapore·CLASS C IVD·Cytocell Limited·Registered November 06, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Pathology
Registration information
- Registration Number
- DE0510011
- Registration Date
- November 06, 2024
- Retention Due Date
- November 05, 2025
Product description
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.
Product Owner
- Name
- Cytocell Limited
- Short Name
- Cytocell Limited
- Address
- 418 Cambridge Science Park, Milton Road, Cambridge CB4 0PZ, UNITED KINGDOM
Registrant
- Address
- 9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
- Address
- 9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model information
- Model Name(s)
- CKS1B/CDKN2C (P18) Amplification/ Deletion Probe CKS1B/CDKN2C (P18) Amplification/ Deletion Probe
- Model Identifier(s)
- CE-LPH 039 CE-LPH 039-S
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD