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Siemens CLINITEST hCG Pregnancy Test - HSA Registration DE0012853

Access comprehensive regulatory information for Siemens CLINITEST hCG Pregnancy Test 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 DE0012853 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on May 08, 2013.

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.

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CLASS B IVD
DE0012853
Siemens CLINITEST hCG Pregnancy Test
HSA Registration Number: DE0012853
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Product Description

The Siemens Healthcare Diagnostics CLINITEST hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in female human urine specimens. Automated: The test is utilized with CLINITEK Statusยฎ+ analyzer and is intended for professional use in near patient (point of care) and centralized laboratory locations. The CLINITEST hCG assay is intended for use as an aid in the early detection of pregnancy.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0012853
Registration Date
May 08, 2013
Change Notification Approval Date
May 07, 2025
Retention Due Date
May 07, 2026
Product Owner
Short Name
Siemens Health
Address
511 Benedict Avenue, Tarrytown, New York 10591-5097, New York, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Clinitek Statusยฎ+ Analyzer CLINITEK Status Connector Chek-Stix UA Diptube Liquid QC CLINITEST hCG Pregnancy test
Model Identifier(s)
10379676 11537761 11561694 1760 (10310618)