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Singapore HSA registration DE0510441

Leica BOND Ready-to-Use Primary Antibody Immunochemistry Antibody (Other Cancer Markers)

Singapore flagSingapore·CLASS B IVD·Leica Biosystems Newcastle Ltd·Registered March 08, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0510441
Registration Date
March 08, 2025
Retention Due Date
March 07, 2026
Product description
The BOND MMR antibody panel is indicated for the detection of mismatch repair protein deficiency as an aid in the identification of hereditary nonpolyposis colorectal cancer (HNPCC)/Lynch Syndrome or sporadic CRC with MMR deficiency in patients diagnosed with CRC. 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. Intended for use on the Leica Biosystems automated BOND-MAX, BOND-III or BOND-PRIME systems using the BOND Polymer Refine Detection kit (DS9800) or BOND-PRIME Polymer DAB Detection System (DS9284).
Product Owner
Name
Leica Biosystems Newcastle Ltd
Short Name
Leica Biosystems Newcastle Ltd
Address
Balliol Business Park West, 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)
MLH1 (Mismatch Repair Protein) MSH2 (Mismatch Repair Protein) MSH6 (Mismatch Repair Protein) PMS2 (Mismatch Repair Protein)
Model Identifier(s)
PA0988 PA0989 PA0990 PA0991
About this record

Access comprehensive regulatory information for Leica BOND Ready-to-Use Primary Antibody Immunochemistry Antibody (Other Cancer Markers) 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 DE0510441 and owned by Leica Biosystems Newcastle Ltd. The device was registered on March 08, 2025.

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