HSA · registration DE0509670Bio-Rad D-100 Hemoglobin Testing System
- Registration number
- DE0509670
- Model name
- D-100 TLA; D-100 Hemoglobin Testing System; D-100 Hemoglobin Testing System
- Model identifier
- 12006848; 12008984; 290-1000
- Registration date
- August 21, 2024
- Risk class
- Class B
- Product owner
- Bio-Rad Laboratories, Inc
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
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 address
- Clinical Diagnostics Group, 4000 Alfred Nobel Drive, Hercules, California 94547, United States
- Registrant address
- 3A INTERNATIONAL BUSINESS PARK, #11-10/16, ICON@IBP, Singapore 609935
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.