Singapore HSA registration DE0012853
Siemens CLINITEST hCG Pregnancy Test
Singapore·CLASS B IVD·Simens Healthcare Diagnostics Inc.·Registered May 08, 2013Device 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 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 Status®+ 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.
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 Status®+ Analyzer CLINITEK Status Connector Chek-Stix UA Diptube Liquid QC CLINITEST hCG Pregnancy test
- Model Identifier(s)
- 10379676 11537761 11561694 1760 (10310618)
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD