Singapore HSA registration DE0013069
Leica Biosystems Bond Ready-To-Use Primary Antibody Cytokeratin 8/18
Singapore·CLASS B IVD·Leica Biosystems Newcastle Ltd·Registered June 03, 2013Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0013069
- Registration Date
- June 03, 2013
- Change Notification Approval Date
- September 26, 2019
- Retention Due Date
- June 02, 2025
Product description
This reagent is for in vitro diagnostic use. Cytokeratin 8/18 (5D3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratin 8 and 18 intermediate filaments in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond 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
- Short Name
- Leica Biosystems Newcastle Ltd
- Address
- Balliol Business Park West, Benton Lane, Newcastle upon Tyne NE12 8EW, UNITED KINGDOM
Registrant
- Address
- 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
- Address
- 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
- Model Name(s)
- BOND-MAX Processing Module Bond System Control Kit BOND-III Processing Module Bond Aspirating Probe Cleaning System Bond Polymer Refine Detection Bond Open Container 7 mL Bond Open Container 30 mL Bond Titration Kit Bond Titration Container Inserts – 50 Pack Ready-to-Use Primary Antibody Cytokeratin 8/18 Bond Slide Tray Bond Aspirating Probe Bond External Waste Container, 9 L Bond Reagent Tray Bond Slide Labeler - Printing Ribbon Bond Slide Labeler - cleaning pen Bond Syringe Bond Mixing Stations Bond Universal Slide Label Covers Bond Universal Covertiles – 100 Pack Leica Bond Plus slides Bond Covertile Cleaning Rack Bond Syringe for 9 Port Pump Bond Slide Labels and Printer Ribbon BOND-III Syringes Bond LIS-ip Package
- Model Identifier(s)
- 21.0051 21.1950 21.2201 CS9100 DS9800 OP79193 OP79700 OPT9049 OPT9719 PA0067 S21.0304 S21.0605 S21.0691 S21.1003 S21.1912 S21.1913 S21.1926 S21.1971 S21.1985 S21.2001 S21.2113 S21.2129 S21.2131 S21.4564 S21.4565 S21.7591
About this record
Access comprehensive regulatory information for Leica Biosystems Bond Ready-To-Use Primary Antibody Cytokeratin 8/18 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 DE0013069 and owned by Leica Biosystems Newcastle Ltd. The device was registered on June 03, 2013.
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