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Thermo Scientific Brilliance™ Candida Agar - HSA Registration DE0509601

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.

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CLASS B IVD
DE0509601
Thermo Scientific Brilliance™ Candida Agar
HSA Registration Number: DE0509601
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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.

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 Owner
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