Singapore HSA registration DE0506554
Fujifilm Wako µTASWako AFP-L3
Singapore·CLASS C IVD·FUJIFILM Wako Pure Chemical Corporation·Registered January 03, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506554
- Registration Date
- January 03, 2022
- Change Notification Approval Date
- December 24, 2024
- Retention Due Date
- January 02, 2026
Product description
The μTASWako AFP-L3 is an immunofluorescence assay to be used with μTASWako i30 analyzer for the quantitative determination of the ratio of lectin-reactive alpha-fetoprotein (AFP-L3%) and alpha-fetoprotein (AFP) in human serum as an aid in the diagnosis of malignant tumor. This product is intended for professional use
Product Owner
- Short Name
- FUJIFILM Wako Pure Chemical Corporation
- Address
- 1-2, Doshomachi, 3 Chome, Chuo-ku,, Osaka 540-8605 Japan, JAPAN
Registrant
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
- Model Name(s)
- μTASWako AFP-L3 Control L μTASWako i30 μTASWako Wash Solution μTASWako Chip Cassette μTASWako AFP-L3 μTASWako AFP-L3 Calibrator Set μTASWako AFP-L3 Control H μTASWako Sample Dilution Buffer
- Model Identifier(s)
- 991-66602 991-67202 991-69402 993-61601 993-66302 995-66502 997-66702 997-69502
About this record
Access comprehensive regulatory information for Fujifilm Wako µTASWako AFP-L3 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 DE0506554 and owned by FUJIFILM Wako Pure Chemical Corporation. The device was registered on January 03, 2022.
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