HSA · registration DE0508566

Abbott Alinity c Lactic Acid2

Name: Abbott Alinity c Lactic Acid2 — HSA DE0508566
Creator: Abbott Ireland Diagnostics Division
Keywords: Abbott Alinity c Lactic Acid2, Abbott Alinity c Lactic Acid2, DE0508566, Clinical chemistry, HSA

SingaporeClinical chemistryClass BAbbott Ireland Diagnostics Division

Verified

Official record identity

Registration number: DE0508566
Model name: Alinity c Lactic Acid2 Assay File; Lactic Acid2; Consolidated Chemistry Calibrator
Model identifier: 04U26-1A; 04U2620; 04V6201
Registration date: October 13, 2023

Classification

Risk class: Class B
Published category: Clinical chemistry

Published parties

Product owner: Abbott Ireland Diagnostics Division
Registrant / registration holder: ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Official description

The Lactic Acid2 assay is used for the quantitation of lactic acid in human plasma on the Alinity c system. 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).

Additional source fields

Product owner address: Lisnamuck, Longford, Co. Longford, Ireland
Registrant address: 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.