HSA · registration DE0507646

Ortho-Clinical Resolve® Panel B

Name: Ortho-Clinical Resolve® Panel B — HSA DE0507646
Creator: Ortho-Clinical Diagnostics
Keywords: Ortho-Clinical Resolve® Panel B, Ortho-Clinical Resolve® Panel B, DE0507646, Hematology, HSA

SingaporeHematologyClass DOrtho-Clinical Diagnostics

Verified

Official record identity

Registration number: DE0507646
Model name: Resolve Panel B
Model identifier: 6901866
Registration date: January 03, 2023
Source update date: March 08, 2023

Classification

Risk class: Class D
Published category: Hematology

Published parties

Product owner: Ortho-Clinical Diagnostics
Registrant / registration holder: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.

Official description

Qualitative test to detect and/or identify unexpected blood group antibodies.

Additional source fields

Product owner address: Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
Registrant address: 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917

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.