Singapore HSA registration DE0015276

Leica Bond Immunohistochemistry antibodies (Cancer Markers)

Singapore·CLASS B IVD·Leica Biosystems Newcastle Ltd·Registered April 30, 2014

Device classification

Device Class: CLASS B IVD
Medical Speciality Area: Immunology
HSA Product Code: HSAMDB00106
HS Code: 38220090

Registration information

Registration Number: DE0015276
Registration Date: April 30, 2014
Change Notification Approval Date: September 19, 2024
Retention Due Date: April 29, 2026

Product description

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

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: LEICA MICROSYSTEMS (SEA) PTE LTD
Address: 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299

Model information

Model Name(s): BOND-MAX Processing Module BOND-III Processing Module Anti-Biotin Antibody Bond Stringency Wash Solution Bond Dewax Solution Bond Primary Antibody Diluent Bond DAB Enhancer Bond Enzyme Pretreament Kit Bond Wash Solution 10X Concentrate Bond Epitope Retrieval Solution 2 Bond Epitope Retrieval Solution 1 Bond Polymer Refine Detection Bond Prostatic Acid Phosphatase Bond Cytoceratin 20 (7mL) Bond Thyroglobulin Bond Glial Fibrillary Acidic Protein Bond Melanoma Marker Bond Desmin Bond Vimentin Bond Epithelial Membrane Antigen Cytoceratin 20 (30mL) Bond CD15 Bond CD45 Bond Melan A Bond Mismatch Repair Protein (MSH2) Bond p53 Protein (DO-7) Bond Cytokeratin (8/18) Bond Cytokeratin 14 Bond Beta-Catenin Bond CD138 (Syndecan 1) Bond Tartrate-Resistant Acid Phosphatase (TRAP) Bond p63 Bond Villin Bond Inhibin (alpha) Bond Cytokeratin 17 Bond bcl-2 Oncoprotein Bond Ki67 Antigen Bond CD3 Bond Multiple Myeloma Oncogene 1 (MUM-1) Bond Cytokeratin, Multi (1/5/10/14) Bond Cytokeratin 7 Bond CD45RO Bond CD30 Bond Placental Alkaline Phosphatase Bond CD5 Bond CD23 Bond CD21 Bond CD8 Bond CD56 (NCAM) Bond CD79a Bond bcl-6 Oncoprotein Bond CD34 (Endothelial Cell Marker) Bond DOG-1 Bond Myogenin (Myf-4) Bond Ki67 Antigen Bond Melan A Bond CD1a Bond Galectin-3 Bond CD22 Bond CD31 (PECAM-1) Bond CD7 Bond CD10 Bond CD2 Bond CD68 (514H12) Bond Synaptophysin Bond CD25 (Interleukin-2 Receptor) Bond CD246 (Anaplastic Lymphoma Kinase) (ALK) (p80) Bond CD61 (GPIIIa) Bond Tyrosinase Bond Somatostatin Bond Terminal Deoxynucleotidyl Transferase Bond Calretinin (CAL6) Bond Gross Cystic Disease Fluid Protein-15 Bond CD34 Bond Thyroid Transcription Factor-1 Bond CD4 (Interleukin-2 Receptor) Bond Neurofilament 200 kD Bond Mesothelin Bond E-Cadherin Bond Muramidase (Lysozyme) Bond Human von Willebrand Factor (Factor VIII-related antigen) Bond Calponin (Basic) Bond Fascin Bond Chromogranin A Bond Neuron Specific Enolase Bond CD57 Bond Cytokeratin 5 Bond p63 Protein Bond Myeloperoxidase Bond Myosin Heavy Chain Antibodies Bond CD99 Bond Oct-2 Bond CDX2 Bond Pax-5 Bond CD3 Bond CD11c Bond CD33 Bond B Cell Specific Octamer Binding Protein1 (BOB-1) Bond Wilms' Tumor Bond Cytokeratin 8 Bond Glucagon Bond Mismatch Repair Protein (MSH6) Bond Mismatch Repair Protein (MLH1) Bond Insulin Bond Melanoma Marker Bond Vimentin Bond Gastrin Bond Human Growth Hormone (HGH) Bond Gross Cystic Disease Fluid Protein 15 Bond Myoglobin Bond Serotonin Bond Thyroid Stimulating Hormone Bond CD30 Bond Cytokeratin 19 Bond CD19 Bond S-100 Bond CD20 Bond Cytokeratin, Multi Bond Cytokeratin 20 Bond Oct-3/4 Bond CD43 Bond Cytokeratin 7 Bond SMA (Alpha Smooth Muscle Actin) Bond ZAP-70
Model Identifier(s): 21.0051 21.2201 AR0584 AR0633 AR9222 AR9352 AR9432 AR9551 AR9590 AR9640 AR9961 DS9800 PA0006 PA0022 PA0025 PA0026 PA0027 PA0032 PA0033 PA0035 PA0037 PA0039 PA0042 PA0044 PA0048 PA0057 PA0067 PA0074 PA0083 PA0088 PA0093 PA0103 PA0106 PA0110 PA0114 PA0117 PA0118 PA0122 PA0129 PA0134 PA0138 PA0146 PA0153 PA0161 PA0168 PA0169 PA0171 PA0183 PA0191 PA0192 PA0204 PA0212 PA0219 PA0226 PA0230 PA0233 PA0235 PA0238 PA0249 PA0250 PA0266 PA0270 PA0271 PA0273 PA0299 PA0305 PA0306 PA0308 PA0322 PA0331 PA0339 PA0346 PA0350 PA0354 PA0364 PA0368 PA0371 PA0373 PA0387 PA0391 PA0400 PA0416 PA0420 PA0430 PA0435 PA0443 PA0468 PA0478 PA0491 PA0493 PA0509 PA0532 PA0535 PA0552 PA0553 PA0554 PA0555 PA0558 PA0562 PA0567 PA0594 PA0597 PA0610 PA0620 PA0625 PA0640 PA0681 PA0704 PA0708 PA0727 PA0736 PA0776 PA0790 PA0799 PA0843 PA0900 PA0906 PA0909 PA0918 PA0934 PA0938 PA0942 PA0943 PA0998

About this record

Access comprehensive regulatory information for Leica Bond Immunohistochemistry antibodies (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 DE0015276 and owned by Leica Biosystems Newcastle Ltd. The device was registered on April 30, 2014.

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