HSA · registration DE0509697

Siemens Atellica IM® Herpes-2 IgG (HSV2)

Name: Siemens Atellica IM® Herpes-2 IgG (HSV2) — HSA DE0509697
Creator: Siemens Healthcare Diagnostics Inc
Keywords: Siemens Atellica IM® Herpes-2 IgG (HSV2), Siemens Atellica IM® Herpes-2 IgG (HSV2), DE0509697, Immunology, HSA

SingaporeImmunologyClass CSiemens Healthcare Diagnostics Inc

Verified

Official record identity

Registration number: DE0509697
Model name: Atellica IM Herpes-2 IgG (HSV2); Atellica IM Herpes-2 IgG Quality Control
Model identifier: 10733033; 10733034
Registration date: August 28, 2024

Classification

Risk class: Class C
Published category: Immunology

Published parties

Product owner: Siemens Healthcare Diagnostics Inc
Registrant / registration holder: SIEMENS HEALTHCARE PTE. LTD.

Official description

The Atellica IM® Herpes-2 IgG (HSV2) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. This assay is intended for use as an aid in the determination of serological status to HSV-2 and in the diagnosis of herpes simplex virus infection.

Additional source fields

Product owner address: 511 Benedict Avenue, Tarrytown, NY 10591, United States
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.