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HSA · registration DE0017819

Siemens N Antiserum to Human Anti-Thrombin III

SingaporeImmunologyClass BSiemens Healthcare Diagnostics Products GmbH
Official record identity
Registration number
DE0017819
Model name
N Antiserum to Human Antithrombin III; N Protein Standard PY; N Reaction Buffer; N Diluent; N Supplementary Reagent/Precipitation; N/T Protein Control PY
Model identifier
OSAY09; 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 AS ATIII is an in vitro diagnostic reagent for the quantitative determination of antithrombin concentration as aid to diagnosis and monitoring of congenital or acquired antithrombin deficiencies in patients at risk for or suspected to have antithrombin deficiency in human sodium citrated plasma by means of immunonephelometry using the automated Siemens Healthineers immuno-nephelometry systems. N AS ATIII 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.