HSA · registration DE0502711Instrumentation Laboratory HemosIL Protein S Activity
SingaporeHematologyClass BInstrumentation Laboratory Company
Official record identity
- Registration number
- DE0502711
- Model name
- HemosIL Factor Diluent; HemosIL Normal Control ASSAYED; HemosIL Low Abnormal Control; HemosIL Calibration Plasma; HemosIL Protein S Activity
- Model identifier
- 0009757600; 0020003110; 0020003210; 0020003700; 0020302000
- Registration date
- January 23, 2019
- Source update date
- June 07, 2019
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Instrumentation Laboratory Company
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
Official description
Automated coagulation functional assay for the quantitative determination of free Protein S in human citrated plasma on the ACL TOP® Family, ACL ELITE®/ELITE PRO/8/9/10000, ACL Advance and ACL Classic (100-7000) Systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.
Additional source fields
- Product owner address
- 180 Hartwell Road, Bedford MA, 01730-2443, United States
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
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.