HSA · registration DE0509243

Biokit Alinity c Digitoxin

Name: Biokit Alinity c Digitoxin — HSA DE0509243
Creator: Biokit S.A.
Keywords: Biokit Alinity c Digitoxin, Biokit Alinity c Digitoxin, DE0509243, Clinical chemistry, HSA

SingaporeClinical chemistryClass CBiokit S.A.

Verified

Official record identity

Registration number: DE0509243
Model name: Alinity c Digitoxin Assay File; Alinity c Digitoxin Standard; Alinity c Digitoxin Controls; Alinity c Digitoxin Reagent Kit
Model identifier: 01R11-1A; 01R1101; 01R1110; 01R1122
Registration date: April 29, 2024

Classification

Risk class: Class C
Published category: Clinical chemistry

Published parties

Product owner: Biokit S.A.
Registrant / registration holder: ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Official description

The Alinity c Digitoxin assay is used for the quantitative determination of digitoxin in human serum on the Alinity c analyzer.

Additional source fields

Product owner address: Av. Can Montcau 7, 08186 Lliçà d'Amunt, Barcelona, Spain
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.