Singapore HSA registration DE0015994
OXOID Staphylase Test Kit
Singapore·CLASS B IVD·OXOID Limited·Registered July 17, 2014Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0015994
- Registration Date
- July 17, 2014
- Change Notification Approval Date
- May 14, 2025
- Retention Due Date
- July 16, 2025
Product description
The Staphylase Test is a qualitative, sheep red blood cell slide agglutination test to aid in the differentiation of Staphylococcus aureus from other Staphylococcus species isolates grown on agar by the detection of clumping factor. Used in a diagnostic workflow to aid clinicians in treatment options for patients suspected of having bacterial infections. The device is not automated, is for professional use only and is not a companion diagnostic.
Product Owner
- Name
- OXOID Limited
- Short Name
- OXOID Limited
- Address
- Wade Road, Basingstoke, Hampshire, RG24 8PW, UNITED KINGDOM
Registrant
- Address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
- Address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model information
- Model Name(s)
- Staphylase Tests
- Model Identifier(s)
- DR0595A
About this record
Access comprehensive regulatory information for OXOID Staphylase Test Kit 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 DE0015994 and owned by OXOID Limited. The device was registered on July 17, 2014.
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