Pure Global

Siemens N Antiserum to Human Anti-Thrombin III - HSA Registration DE0017819

Access comprehensive regulatory information for Siemens N Antiserum to Human Anti-Thrombin III 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 DE0017819 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0017819
Siemens N Antiserum to Human Anti-Thrombin III
HSA Registration Number: DE0017819
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product 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.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0017819
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 Antithrombin III 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 OSAY09 OUID13 OUMS61 OUMS65 OUMT05 OUMU15 OVIA11 OVLI01 OVLI02 (11239861) OWSY13