Singapore HSA registration DE0508906
Sekisui Diagnostics ARCHITECT Acetaminophen
Singapore·CLASS B IVD·Sekisui Diagnostics P.E.I. Inc.·Registered January 30, 2024Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD