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Remel Shigella Polyvalent Agglutinating Sera - HSA Registration DE0016001

Access comprehensive regulatory information for Remel Shigella Polyvalent Agglutinating Sera 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 DE0016001 and owned by Remel Europe 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
DE0016001
Remel Shigella Polyvalent Agglutinating Sera
HSA Registration Number: DE0016001
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Product Description

Shigella Polyvalent Agglutinating Sera are suitable for use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes. Antisera provide serological identification only; full identification of an organism must be made in conjunction with biochemical testing.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0016001
Registration Date
July 17, 2014
Retention Due Date
July 16, 2025
Product Owner
Short Name
Remel Europe Limited
Address
Remel House, Clipper Boulevaard West, Crossways, Dartford, Kent DA2 6PT, 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)
Shigella dysenteriae Polyvalent Agglutinating Sera Shigella flexneri Polyvalent Agglutinating Sera Shigella boydii Polyvalent 1 Agglutinating Sera Shigella boydii Polyvalent 2 Agglutinating Sera Shigella boydii Polyvalent 3 Agglutinating Sera Shigella sonnei Phases 1& 2 Agglutinating Sera
Model Identifier(s)
R30163701 R30163801 R30163901 R30164001 R30164101 R30164201