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Singapore HSA registration DE0506051

Leica Novocastra™ Immunohistochemistry Antibody (Other cancer markers)

Singapore flagSingapore·CLASS B IVD·Leica Biosystems Newcastle Ltd·Registered August 06, 2021
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0506051
Registration Date
August 06, 2021
Change Notification Approval Date
June 27, 2024
Retention Due Date
August 05, 2025
Product description
Intended for the qualitative identification by light microscopy of cancer marker molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using 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)
Novocastra Multi-Cytokeratin Novocastra CD163 Novocastra Epidermal Growth Factor Receptor Novocastra Oct-3/4
Model Identifier(s)
NCL-L-AE1/AE3-601 NCL-L-CD163 NCL-L-EGFR NCL-L-OCT3/4
About this record

Access comprehensive regulatory information for Leica Novocastra™ Immunohistochemistry 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 DE0506051 and owned by Leica Biosystems Newcastle Ltd. The device was registered on August 06, 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