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HSA · registration DE0018388

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

SingaporeClinical chemistryClass BSiemens Healthcare Diagnostics Products GmbH
Official record identity
Registration number
DE0018388
Model name
N Apolipoprotein A-II Kit; N Apolipoprotein E Kit; N Reaction Buffer; N Diluent; N Apolipoprotein Standard Serum; Apolipoprotein Control Serum CHD (human)
Model identifier
OQBA09; OQDL09; OUMS61; OUMT05; OUPG07; OUPH07
Registration date
July 20, 2016
Source update date
October 01, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Clinical chemistry
Published parties
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official 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.

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.