Singapore HSA registration DE0510604
Leica BOND Ready-to-Use Primary Antibody Mammaglobin (EP249)
Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510604
- Registration Date
- April 17, 2025
- Retention Due Date
- April 16, 2026
Product description
Mammaglobin (EP249) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human mammaglobin protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). Mammaglobin (EP249) is recommended to identify cells originating from breast or exhibiting mammary differentiation. 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. Mammaglobin (EP249) is recommended for use on tissue specimens from patients with suspected lesions of the breast, as an adjunct to conventional histopathology using non-immunologic histochemical stains.
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
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
- Model Name(s)
- BOND Mammaglobin (EP249)
- Model Identifier(s)
- PA0378
About this record
Access comprehensive regulatory information for Leica BOND Ready-to-Use Primary Antibody Mammaglobin (EP249) in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510604 and owned by Leica Biosystems Newcastle Ltd. The device was registered on April 17, 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 C IVD