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Fujifilm Wako μTASWako PIVKAII - HSA Registration DE0018721

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.

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CLASS C IVD
DE0018721
Fujifilm Wako μTASWako PIVKAII
HSA Registration Number: DE0018721
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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.

Device 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 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