HSA · registration DE0509699

Abbott Alinity c Calcium2

Name: Abbott Alinity c Calcium2 — HSA DE0509699
Creator: Abbott Ireland Diagnostics Division
Keywords: Abbott Alinity c Calcium2, Abbott Alinity c Calcium2, DE0509699, Clinical chemistry, HSA

SingaporeClinical chemistryClass BAbbott Ireland Diagnostics Division

Verified

Official record identity

Registration number: DE0509699
Model name: Alinity c Calcium2 Assay File; Alinity c Calcium2 Assay File; Calcium2; Calcium2; Consolidated Chemistry Calibrator
Model identifier: 04T87-1A; 04T87-3A; 04T8720; 04T8730; 04V6201
Registration date: August 28, 2024

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 Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the Alinity c system. 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).

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.