HSA · registration DE0510538

Diagast Anti-A, Anti-B, Anti-A,B (PK1) Blood Grouping Reagents

Name: Diagast Anti-A, Anti-B, Anti-A,B (PK1) Blood Grouping Reagents — HSA DE0510538
Creator: Diagast
Keywords: Diagast Anti-A, Anti-B, Anti-A,B (PK1) Blood Grouping Reagents, Diagast Anti-A, Anti-B, Anti-A,B (PK1) Blood Grouping Reagents, DE0510538, Hematology, HSA

SingaporeHematologyClass DDiagast

Verified

Official record identity

Registration number: DE0510538
Model name: Anti-A (PK1); Anti-B (PK1); Anti-A,B (PK1); CONTROL PK; BROMELINE PK
Model identifier: B10328; B10329; B10330; B10350; B10351
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

Anti-A, Anti-B, Anti-A,B (PK1) are in vitro diagnostic medical devices (IVDMD) intended to be used by healthcare professionals, biologists or lab technicians for the qualitative detection of red blood cell antigens in donor blood samples with anticoagulant (EDTA) using a microplate automated method. The determination of the forward (antigen) typing with the reverse (antibody) 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.