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Leica BOND Ready To Use Primary Antibodies Immunohistochemistry (IHC- Hematologic Disorder and blood cancer marker) - HSA Registration DE0505428

Access comprehensive regulatory information for Leica BOND Ready To Use Primary Antibodies Immunohistochemistry (IHC- Hematologic Disorder and blood cancer marker) 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 DE0505428 and owned by Leica Biosystems Newcastle Ltd. The device was registered on February 03, 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.

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CLASS B IVD
DE0505428
Leica BOND Ready To Use Primary Antibodies Immunohistochemistry (IHC- Hematologic Disorder and blood cancer marker)
HSA Registration Number: DE0505428
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Product Description

Intended to be used for the qualitative identification by light microscopy of human light chains in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0505428
Registration Date
February 03, 2021
Retention Due Date
February 02, 2026
Product Owner
Short Name
Leica Biosystems Newcastle Ltd
Address
Balliol Business Pk/Benton La, Newcastle upon Tyne NE12 8EW, UNITED KINGDOM
Registrant
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model Information
Model Name(s)
Lambda Light Chain (SHL53) Kappa Light Chain (CH15)
Model Identifier(s)
PA0570 PA0606