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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.

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CLASS B IVD
DE0508906
Sekisui Diagnostics ARCHITECT Acetaminophen
HSA Registration Number: DE0508906
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Product Description

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.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0508906
Registration Date
January 30, 2024
Retention Due Date
January 29, 2026
Product Owner
Short Name
Sekisui Diagnostics P.E.I. Inc.
Address
70 Watts Avenue, Charlottetown, PE C1E 2B9, CANADA
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Acetaminophen Calibrator Acetaminophen ARCHITECT Aceta2 e-Assay CD-ROM ARCHITECT Aceta2 e-Assay CD-ROM
Model Identifier(s)
03R7401 03R7420 3R74-1A 3R74-3A