Pure Global

Bio-Rad D-100 Hemoglobin Testing System - HSA Registration DE0509670

Access comprehensive regulatory information for Bio-Rad D-100 Hemoglobin Testing System in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509670 and owned by Bio-Rad Laboratories, Inc. The device was registered on August 21, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0509670
Bio-Rad D-100 Hemoglobin Testing System
HSA Registration Number: DE0509670
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Bio-Rad D-100 Hemoglobin Testing System performs automated analysis of whole blood samples within the clinical laboratory. With advanced automation and high-throughput operation, the D-100 generates highโ€‘quality results using high-performance liquid chromatography (HPLC) technology with an efficient and flexible testing workflow. The D-100 System consists of a fully-integrated standalone workstation of automated HPLC instrumentation that includes an onboard computer. The software operating the instrumentation is controlled through a graphical user interface via an onboard touchscreen. The D-100 is intended for use only with Bio-Rad D-100 assays. It must be operated by trained laboratory staff within a conventional laboratory environment.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0509670
Registration Date
August 21, 2024
Retention Due Date
August 20, 2025
Product Owner
Short Name
Bio-Rad Laboratories, Inc
Address
Clinical Diagnostics Group, 4000 Alfred Nobel Drive, Hercules, California 94547, UNITED STATES
Registrant
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model Information
Model Name(s)
D-100 TLA D-100 Hemoglobin Testing System D-100 Hemoglobin Testing System
Model Identifier(s)
12006848 12008984 290-1000