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Siemens N Antiserum to Human C1-Inhibitor - HSA Registration DE0017820

Access comprehensive regulatory information for Siemens N Antiserum to Human C1-Inhibitor 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 DE0017820 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.

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CLASS B IVD
DE0017820
Siemens N Antiserum to Human C1-Inhibitor
HSA Registration Number: DE0017820
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Product Description

N Antiserum to Human C1-Inhibitor is an in vitro diagnostic reagent for the quantitative determination of C1-Inhibitor concentration as aid to diagnosis of congenital or acquired C1-Inhibitor deficiencies in patients at risk for or suspected to have C1-Inhibitor deficiency in human serum and sodium citrated plasma by means of automated Siemens Healthineers immuno-nephelometry systems. N Antiserum to Human C1-Inhibitor uses a calibration against an internal protein reference preparation.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0017820
Registration Date
January 26, 2016
Change Notification Approval Date
October 01, 2024
Retention Due Date
January 25, 2026
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 C1-Inhibitor 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 OQEY09 OUID13 OUMS61 OUMS65 OUMT05 OUMU15 OVIA11 OVLI01 OVLI02 (11239861) OWSY13