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Fujifilm Wako µTASWako AFP-L3 - HSA Registration DE0506554

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.

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CLASS C IVD
DE0506554
Fujifilm Wako µTASWako AFP-L3
HSA Registration Number: DE0506554
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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

Device 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 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