HSA · registration DE0506449Instrumentation Laboratory HemosIL AcuStar ADAMTS13 Activity
- Registration number
- DE0506449
- Model name
- HemosIL AcuStar ADAMTS13 Activity; HemosIL AcuStar ADAMTS13 Activity Reagent Cartridge; HemosIL AcuStar ADAMTS13 Act 1mL Calibrator 0; HemosIL AcuStar ADAMTS13 Act 1mL Calibrator 1; HemosIL AcuStar ADAMTS13 Act 1mL Calibrator 2; HemosIL AcuStar ADAMTS13 Act 1.8mL Buffer; HemosIL AcuStar VWF Controls
- Model identifier
- 0009802048; 0009802049; 0009802050; 0009802051; 0009802052; 0009802053; 0009802119
- Registration date
- December 06, 2021
- Risk class
- Class B
- Product owner
- Instrumentation Laboratory Company
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
The HemosIL AcuStar ADAMTS13 Activity is a quantitative, fully automated, chemiluminescent immunoassay (CIA) for the measurement of ADAMTS13 Activity. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL AcuStar® in a laboratory setting by healthcare professionals. The assay results aid in the diagnosis and monitoring of Thrombotic Thrombocytopenic Purpura (TTP). The results should be used in conjunction with other clinical and laboratory findings. For use in adult population. For prescription use only
- Product owner address
- 180 Hartwell Road, Bedford MA 01730, United States of America, United States
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
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.