Singapore HSA registration DE0502280
Freenome Early CDT-Lung Test Kit
Singapore·CLASS C IVD·Freenome Ltd·Registered October 22, 2018Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0502280
- Registration Date
- October 22, 2018
- Change Notification Approval Date
- June 04, 2024
- Retention Due Date
- October 21, 2025
Product description
“The EarlyCDT Lung test kit is intended to be used as an immunoassay for the in vitro detection of a panel of seven lung cancer autoantibodies in humans to aid in the early detection of lung cancer in high-risk patients and risk stratification of patients with indeterminate pulmonary nodules identified by CT. The EarlyCDT Lung test kit is designed for professional use and analytical results should be interpreted by medical professionals in combination with all other available clinical information. The test is intended for use with human serum collected in either clot activator or gel tube or plasma collected in EDTA tubes.”
Product Owner
- Name
- Freenome Ltd
- Short Name
- Freenome Ltd
- Address
- MediCity, D6 Building, 1 Thane Road, Nottingham NG90 6BH, UNITED KINGDOM
Registrant
- Name
- WEAVEGEN PTE LTD
- Address
- 1 COLEMAN STREET, THE ADELPHI, #10-06, SINGAPORE 179803
Importer
- Name
- WEAVEGEN PTE LTD
- Address
- 21 TAN QUEE LAN STREET, HERITAGE PLACE, #02-04, SINGAPORE 188108
Model information
- Model Name(s)
- Early CDT-Lung Test Kit
- Model Identifier(s)
- ECDTL2-KIT
About this record
Access comprehensive regulatory information for Freenome Early CDT-Lung Test Kit 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 DE0502280 and owned by Freenome Ltd. The device was registered on October 22, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD