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Singapore HSA registration DE0015993

OXOID PathoDxtra Strep Grouping Kit

Singapore flagSingapore·CLASS B IVD·OXOID Limited·Registered July 17, 2014
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration information
Registration Number
DE0015993
Registration Date
July 17, 2014
Retention Due Date
July 16, 2025
Product description
PathoDxtra Strep Grouping kit is a latex agglutination test which provides a rapid method for the serological identification of Lancefield Groups A, B, C, D, F and G streptococci from primary culture plates. The materials supplied are intended for in vitro diagnostic use, as an aid in the rapid grouping of streptococci.
Product Owner
Name
OXOID Limited
Short Name
OXOID Limited
Address
Wade Road, Basingstoke, Hampshire, RG24 8PW, UNITED KINGDOM
Registrant
Name
THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
Name
THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model information
Model Name(s)
PathoDxtra Strep Grouping Kit PathoDxtra Strep Group A Latex PathoDxtra Strep Group B Latex PathoDxtra Strep Group C Latex PathoDxtra Strep Group D Latex PathoDxtra Strep Group F Latex PathoDxtra Strep Group G Latex PathoDxtra Polyvalent Positive Control PathoDxtra Extraction Reagents - Reagents 1, 2 and 3 PathoDxtra Strep Grouping Reagent Set - Extraction Reagents 1, 2 & 3; Disposable reaction cards (50); wooden sticks; positive control PathoDxtra reaction cards
Model Identifier(s)
DR0700M DR0701G DR0702G DR0703G DR0704G DR0705G DR0706G DR0707G DR0709M DR0710M DR0720G
About this record

Access comprehensive regulatory information for OXOID PathoDxtra Strep 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 DE0015993 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