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Singapore HSA registration DE0505754

Leica Bond Ready-to-Use Primary Antibody S-100 (EP32)

Singapore flagSingapore·CLASS B IVD·Leica Biosystems Newcastle Ltd·Registered May 05, 2021
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0505754
Registration Date
May 05, 2021
Retention Due Date
May 04, 2026
Product description
This reagent is for in vitro diagnostic use. S-100 (EP32) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of S-100B protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
Product Owner
Name
Leica Biosystems Newcastle Ltd
Short Name
Leica
Address
Balliol Business Park, Benton Lane, Newcastle upon Tyne, NE12 8EW, UNITED KINGDOM
Registrant
Name
LEICA MICROSYSTEMS (SEA) PTE LTD
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
Name
BIOMED DIAGNOSTICS PTE LTD LEICA MICROSYSTEMS (SEA) PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
Model Name(s)
BOND Ready-to-use Primary Antibody S-100 (EP32)
Model Identifier(s)
PA0031
About this record

Access comprehensive regulatory information for Leica Bond Ready-to-Use Primary Antibody S-100 (EP32) 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 DE0505754 and owned by Leica Biosystems Newcastle Ltd. The device was registered on May 05, 2021.

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