Singapore HSA registration DE0508565
Abbott ARCHITECT Lactic Acid2
Singapore·CLASS B IVD·Abbott Ireland Diagnostics Division·Registered October 13, 2023Device 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 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).
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD