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Abbott ARCHITECT Lactic Acid2 - HSA Registration DE0508565

Access comprehensive regulatory information for Abbott ARCHITECT Lactic Acid2 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 DE0508565 and owned by Abbott Ireland Diagnostics Division. The device was registered on October 13, 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
DE0508565
Abbott ARCHITECT Lactic Acid2
HSA Registration Number: DE0508565
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Product Description

The Lactic Acid2 assay is used for the quantitation of lactic acid in human plasma on the ARCHITECT c Systems. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0508565
Registration Date
October 13, 2023
Retention Due Date
October 12, 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)
Lactic Acid2 Consolidated Chemistry Calibrator
Model Identifier(s)
04T3020 04V1501