Singapore HSA registration DE0018721
Fujifilm Wako μTASWako PIVKAII
Singapore·CLASS C IVD·FUJIFILM Wako Pure Chemical Corporation·Registered November 08, 2016Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0018721
- Registration Date
- November 08, 2016
- Change Notification Approval Date
- December 24, 2024
- Retention Due Date
- November 07, 2025
Product description
The μTASWako PIVKAII is an immunofluorescence assay to be used with μTASWako i30 analyzer for the quantitative determination of abnormal prothrombin (PIVKA II) 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 i30 μTASWako Wash Solution μTASWako Chip Cassette μTASWako PIVKAII Calibrator Set μTASWako Sample Dilution Buffer μTASWako PIVKAII μTASWako PIVKAII Control L μTASWako PIVKAII Control H
- Model Identifier(s)
- 991-67202 991-69402 993-61601 993-66802 997-69502 999-66402 999-66902 999-67002
About this record
Access comprehensive regulatory information for Fujifilm Wako μTASWako PIVKAII 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 DE0018721 and owned by FUJIFILM Wako Pure Chemical Corporation. The device was registered on November 08, 2016.
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