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OXOID Streptococcal Grouping Kit - HSA Registration DE0015996

Access comprehensive regulatory information for OXOID Streptococcal Grouping 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 DE0015996 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
DE0015996
OXOID Streptococcal Grouping Kit
HSA Registration Number: DE0015996
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Product Description

A latex agglutination test for the identification of streptococcal groups A, B, C, D, F, and G Lancefield showed that the majority of pathogenic streptococci possess specific carbohydrate antigens, which permit the classification of streptococci into groups. These streptococcal group antigens can be extracted from the cells and their presence demonstrated with latex particles previously coated with group-specific antibodies. These latex particles will agglutinate in the presence of homologous antigen, but will remain in smooth suspension in the absence of such antigen. The Oxoid Streptococcal Grouping Kit is such a latex agglutination test for the identification of the streptococcal group, and reagents are provided for groups, A, B, C, D, F, and G. The use of a new enzymatic extraction procedure considerably shortens the time required for antigen extraction and much improves the antigen yield, particularly for Group D streptococci.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0015996
Registration Date
July 17, 2014
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 Streptococcal Grouping Kit Streptococcal Grouping Reagent A Streptococcal Grouping Reagent B Streptococcal Grouping Reagent C Streptococcal Grouping Reagent D Streptococcal Grouping Reagent F Streptococcal Grouping Reagent G Polyvalent Positive Control Extraction Enzyme
Model Identifier(s)
DR0500G DR0585A DR0586G DR0587G DR0588G DR0589G DR0590G DR0591G DR0592G DR0593G