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.
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

