HSA · registration DE0510537

Diagast HEMA Cells A1, B, A2, O (PK1 & PK2)

Name: Diagast HEMA Cells A1, B, A2, O (PK1 & PK2) — HSA DE0510537
Creator: Diagast
Keywords: Diagast HEMA Cells A1, B, A2, O (PK1 & PK2), Diagast HEMA Cells A1, B, A2, O (PK1 & PK2), DE0510537, Hematology, HSA

SingaporeHematologyClass DDiagast

Verified

Official record identity

Registration number: DE0510537
Model name: HEMA CELLS A1, B (PK1); HEMA CELLS A2 (PK1); HEMA CELLS O (PK1); CONTROL PK; BROMELINE PK; HEMA CELLS A1, B (PK2); HEMA CELLS A2 (PK2); HEMA CELLS O (PK2)
Model identifier: B10347; B10348; B10349; B10350; B10351; B10903; B10904; B10905
Registration date: April 02, 2025

Classification

Risk class: Class D
Published category: Hematology

Published parties

Product owner: Diagast
Registrant / registration holder: BECKMAN COULTER SINGAPORE PTE. LTD.

Official description

These reagents are IVDMD intended to be used by healthcare professionals, biologists or lab technicians for the qualitative detection of anti-erythrocytic antibodies to test the ABO reverse blood grouping in donor blood samples with anticoagulant (EDTA) using a microplate automated method. The determination of the reverse (antibody) typing with the forward (antigen) typing in donors is intended to ensure immunological compatibility and safe transfusion of blood and blood components.

Additional source fields

Product owner address: 251 avenue Eugene Avinee, Eurasante Parc, 59120 LOOS FRANCE, France
Registrant address: 11 COLLYER QUAY, #05-06C, THE ARCADE, Singapore 049317

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.