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OXOID Staphytect Plus - HSA Registration DE0015995

Access comprehensive regulatory information for OXOID Staphytect Plus 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 DE0015995 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.

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CLASS B IVD
DE0015995
OXOID Staphytect Plus
HSA Registration Number: DE0015995
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Product Description

Staphytect Plus kit is a qualitative latex slide agglutination test for the differentiation of Staphylococcus aureus from other Staphylococcus species isolates grown on agar by the detection of clumping factor, Protein A and certain capsular polysaccharides found in methicillin-resistant Staphylococcus aureus. Used in a diagnostic workflow to aid clinicians in treatment options for patients suspected of having staphylococcal infection or colonization. The device is not automated, is for professional use only and is not a companion diagnostic

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0015995
Registration Date
July 17, 2014
Change Notification Approval Date
May 06, 2025
Retention Due Date
July 16, 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)
Reaction Cards Staphytect Plus Staphytect Plus
Model Identifier(s)
DR0500G DR0850B DR0850M