HSA · registration DE0017821Siemens N Antiserum to Human Fibrinogen
SingaporeImmunologyClass BSiemens Healthcare Diagnostics Products GmbH
Official record identity
- Registration number
- DE0017821
- Model name
- N Antiserum to Human Fibrinogen; N Protein Standard PY; N Reaction Buffer; N Diluent; N Supplementary Reagent/Precipitation; N/T Protein Control PY
- Model identifier
- OSCA09; OUID13; OUMS61; OUMT05; OUMU15; OWSY13
- Registration date
- January 26, 2016
- Source update date
- October 01, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Siemens Healthcare Diagnostics Products GmbH
- Registrant / registration holder
- SIEMENS HEALTHCARE PTE. LTD.
Official description
N Antiserum to Human Fibrinogen is an in vitro diagnostic reagent for the quantitative, WHO-standardized determination of fibrinogen concentration as an aid to diagnosis of fibrinogen deficiency or dysfibrinogenemia in patients with bleeding or thrombotic disorders in human sodium citrated plasma by means of automated Siemens Healthineers immuno-nephelometry systems.
Additional source fields
- Product owner address
- Emil-von-Behring-Str. 76, 35041 Marburg, Germany
- Registrant address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
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.