Singapore HSA registration DE0509601
Thermo Scientific Brilliance™ Candida Agar
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0509601
- Registration Date
- July 30, 2024
- Retention Due Date
- July 29, 2025
Product description
Brilliance Candida Agar (PO1034A) is a selective differential medium which enables isolation and identification of clinically important Candida spp. from clinical samples, and for identifying clinical isolates. Brilliance Candida Agar (PO1034A) can be used with a variety of sample types; the main sample types are sputum and urine, as well as bronchial secretion, genital, nasal, ear, throat, wound, skin, gastrostomy and central venous line site samples. Brilliance Candida Agar (PO1034A) is used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having candidiasis. The device is for professional use only, is not automated, nor is it 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)
- Brilliance™ Candida Agar
- Model Identifier(s)
- PO1034A
About this record
Access comprehensive regulatory information for Thermo Scientific Brilliance™ Candida Agar 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 DE0509601 and owned by OXOID Limited. The device was registered on July 30, 2024.
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