HSA · registration DE0502710Instrumentation Laboratory HemosIL Proclot
SingaporeHematologyClass BInstrumentation Laboratory Company
Official record identity
- Registration number
- DE0502710
- Model name
- HemosIL ProClot; HemosIL ProClot Diluent; HemosIL Factor Diluent; HemosIL Normal Control ASSAYED; HemosIL Low Abnormal Control; HemosIL Calibration Plasma
- Model identifier
- 0008468310; 0008468600; 0009757600; 0020003110; 0020003210; 0020003700
- 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
For quantitative determination of Protein C in human citrated plasma on IL Hemostasis systems, a test kit containing Protein C activator, Protein C deficient plasma and Protein C control plasma.
Additional source fields
- 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
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.