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Abbott ARCHITECT Phosphorus2 - HSA Registration DE0508678

Access comprehensive regulatory information for Abbott ARCHITECT Phosphorus2 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 DE0508678 and owned by Abbott Ireland Diagnostics Division. The device was registered on November 21, 2023.

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
DE0508678
Abbott ARCHITECT Phosphorus2
HSA Registration Number: DE0508678
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Product Description

The Phosphorus2 assay is used for the quantitation of phosphorus in human serum, plasma, or urine on the ARCHITECT c Systems. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0508678
Registration Date
November 21, 2023
Retention Due Date
November 20, 2025
Product Owner
Short Name
Abbott Ireland Diagnostics Division
Address
Lisnamuck, Longford, Co. Longford, IRELAND
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)
Phosphorus2 Phosphorus2 Consolidated Chemistry Calibrator
Model Identifier(s)
04T0720 04T0730 04V1501