Singapore HSA registration DE0504935
Japan Lyophilization Laboratory HISCL Anti-TP
Singapore·CLASS C IVD·Japan Lyophilization Laboratory·Registered September 17, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0504935
- Registration Date
- September 17, 2020
- Change Notification Approval Date
- October 21, 2024
- Retention Due Date
- September 16, 2025
Product description
Detection of anti-TP antibody (TPAb) in serum or plasma.
Product Owner
- Short Name
- Japan Lyophilization Laboratory
- Address
- Kiyose Factory, 3-1-5 Matsuyama, Kiyose-shi, Tokyo, 204-0022, JAPAN
Registrant
- Address
- 9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
- Address
- 9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model information
- Model Name(s)
- HISCL Anti-TP Assay Kit HISCL Anti-TP Calibrator HISCL Anti-TP Assay Kit
- Model Identifier(s)
- CE-079-700 CJ-914-963 CN-364-470
About this record
Access comprehensive regulatory information for Japan Lyophilization Laboratory HISCL Anti-TP 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 DE0504935 and owned by Japan Lyophilization Laboratory. The device was registered on September 17, 2020.
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