Sekisui Diagnostics ARCHITECT Acetaminophen - HSA Registration DE0508906
Access comprehensive regulatory information for Sekisui Diagnostics ARCHITECT Acetaminophen in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0508906 and owned by Sekisui Diagnostics P.E.I. Inc.. The device was registered on January 30, 2024.
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 Acetaminophen assay is intended for the in vitro quantitative determination of acetaminophen in human serum or plasma on the ARCHITECT c Systems. The acetaminophen assay is to be used as an aid in the diagnosis and treatment of patients suspected of acetaminophen overdose toxicity.

