HSA · registration DE0501450Siemens vWF Ag
SingaporeHematologyClass BSiemens Healthcare Diagnostics Products GmbH
Official record identity
- Registration number
- DE0501450
- Model name
- Dade Owren’s Veronal Buffer; vWF Ag; Imidazole Buffer Solution; Control Plasma N; Standard Human Plasma; Control Plasma P
- Model identifier
- B4234-25; OPAB03; OQAA33; ORKE41; ORKL17; OUPZ17
- Registration date
- March 28, 2018
- Source update date
- August 17, 2022
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Siemens Healthcare Diagnostics Products GmbH
- Registrant / registration holder
- SYSMEX ASIA PACIFIC PTE. LTD.
Official description
vWF Ag is an in vitro diagnostic reagent for the quantitative, WHO-standardized determination of von Willebrand factor (vWF) antigen concentration as aid to diagnosis of congenital or acquired vWF deficiencies in patients with bleeding disorders or at risk for vWF deficiency in human sodium citrated plasma by means of automated immunoturbidimetric methods.
Additional source fields
- Product owner address
- Emil-von-Behring-Str. 76, 35041 Marburg, Germany, Germany
- Registrant address
- 9 TAMPINES GRANDE, #06-18, ASIA GREEN, Singapore 528735
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.