Pure Global
Singapore HSA registration DE0018388

Siemens N Antisera to Human Apolipoprotein A-II and Apolipoprotein E

Singapore flagSingapore·CLASS B IVD·Siemens Healthcare Diagnostics Products GmbH·Registered July 20, 2016
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0018388
Registration Date
July 20, 2016
Change Notification Approval Date
October 01, 2024
Retention Due Date
July 19, 2025
Product description
N APOAII is an in vitro diagnostic reagent for the quantitative IFCC-standardized determination of apolipoprotein A-II (Apo A-II) as an aid in the assessment of high-density lipoprotein (HDL) metabolism defects related to cardiovascular disease and arteriosclerosis in human serum by means of automated Siemens Healthineers immuno- nephelometry systems. N APOE is an in vitro diagnostic reagent for the quantitative determination of apolipoprotein E (Apo E) in human serum as an aid to diagnosis for congenital hyperlipoproteinemia by means of automated Siemens Healthineers immuno-nephelometry systems.
Product Owner
Name
Siemens Healthcare Diagnostics Products GmbH
Short Name
Siemens Healthcare Diagnostics Products GmbH
Address
Emil-von-Behring-Str. 76, 35041 Marburg, GERMANY
Registrant
Name
SIEMENS HEALTHCARE PTE. LTD.
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Name
SIEMENS HEALTHCARE PTE. LTD.
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 Apolipoprotein A-II Kit N Apolipoprotein E Kit N Reaction Buffer N Reaction Buffer N Diluent N Apolipoprotein Standard Serum Apolipoprotein Control Serum CHD (human) BN II System BN ProSpec System Atellica NEPH 630 System
Model Identifier(s)
10987487 OQBA09 OQDL09 OUMS61 OUMS65 OUMT05 OUPG07 OUPH07 OVIA11 OVLI01 OVLI02 (11239861)
About this record

Access comprehensive regulatory information for Siemens N Antisera to Human Apolipoprotein A-II and Apolipoprotein E 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 DE0018388 and owned by Siemens Healthcare Diagnostics Products GmbH. The device was registered on July 20, 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