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Singapore HSA registration DE0505841

Leica BOND Ready-to-Use ISH Probe (FISH -Hematologic Disorder and Blood Cancer Markers)

Singapore flagSingapore·CLASS B IVD·Leica Biosystems Newcastle Ltd·Registered June 03, 2021
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0505841
Registration Date
June 03, 2021
Change Notification Approval Date
February 04, 2025
Retention Due Date
June 02, 2025
Product description
Intended for use in the qualitative identification of light chain messenger RNA (mRNA) in formalin-fixed, paraffin embedded tissue by in situ hybridization (ISH) 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)
Kappa Probe Lambda Probe
Model Identifier(s)
PB0645 PB0669
About this record

Access comprehensive regulatory information for Leica BOND Ready-to-Use ISH Probe (FISH -Hematologic Disorder and Blood 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 DE0505841 and owned by Leica Biosystems Newcastle Ltd. The device was registered on June 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD