Singapore HSA registration DE0509700
Abbott ARCHITECT Calcium2
Singapore·CLASS B IVD·Abbott Ireland Diagnostics Division·Registered August 28, 2024Device 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 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).
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD