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HSA · registration DE0017820

Siemens N Antiserum to Human C1-Inhibitor

SingaporeImmunologyClass BSiemens Healthcare Diagnostics Products GmbH
Official record identity
Registration number
DE0017820
Model name
N Antiserum to Human C1-Inhibitor; N Protein Standard PY; N Reaction Buffer; N Diluent; N Supplementary Reagent/Precipitation; N/T Protein Control PY
Model identifier
OQEY09; 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 category
Immunology
Published parties
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official 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.

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.