Singapore HSA registration DE0017821
Siemens N Antiserum to Human Fibrinogen
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Products GmbH·Registered January 26, 2016Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0017821
- Registration Date
- January 26, 2016
- Change Notification Approval Date
- October 01, 2024
- Retention Due Date
- January 25, 2026
Product 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.
Product Owner
- Short Name
- Siemens Healthcare Diagnostics Products GmbH
- Address
- Emil-von-Behring-Str. 76, 35041 Marburg, GERMANY
Registrant
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- BN ProSpec System AP Update 3.0 CD Kit OUS N Antiserum to Human Fibrinogen N Protein Standard PY N Reaction Buffer N Reaction Buffer N Diluent N Supplementary Reagent/Precipitation BN II System BN ProSpec System Atellica NEPH 630 System N/T Protein Control PY
- Model Identifier(s)
- 10987487 OSCA09 OUID13 OUMS61 OUMS65 OUMT05 OUMU15 OVIA11 OVLI01 OVLI02 (11239861) OWSY13
About this record
Access comprehensive regulatory information for Siemens N Antiserum to Human Fibrinogen in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0017821 and owned by Siemens Healthcare Diagnostics Products GmbH. The device was registered on January 26, 2016.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD