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Abbott ARCHITECT Calcium2 - HSA Registration DE0509700

Access comprehensive regulatory information for Abbott ARCHITECT Calcium2 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 DE0509700 and owned by Abbott Ireland Diagnostics Division. The device was registered on August 28, 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
DE0509700
Abbott ARCHITECT Calcium2
HSA Registration Number: DE0509700
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Product Description

The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509700
Registration Date
August 28, 2024
Retention Due Date
August 27, 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)
Calcium2 Calcium2 Consolidated Chemistry Calibrator
Model Identifier(s)
04S9120 04S9130 04V1501