Singapore HSA registration DE0509670
Bio-Rad D-100 Hemoglobin Testing System
Singapore·CLASS B IVD·Bio-Rad Laboratories, Inc·Registered August 21, 2024Device 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 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 high‑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.
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
About this record
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 DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD