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Singapore HSA registration DE0507155

Leica Bond Ready to Use Primary Antibody Human Chorionic Gonadotrophin (Polyclonal)

Singapore flagSingapore·CLASS B IVD·Leica Biosystems Newcastle Ltd·Registered August 10, 2022
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0507155
Registration Date
August 10, 2022
Retention Due Date
August 09, 2025
Product description
Human Chorionic Gonadotrophin (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human chorionic gonadotrophin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an 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)
Human Chorionic Gonadotrophin (Polyclonal)
Model Identifier(s)
PA0014
About this record

Access comprehensive regulatory information for Leica Bond Ready to Use Primary Antibody Human Chorionic Gonadotrophin (Polyclonal) 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 DE0507155 and owned by Leica Biosystems Newcastle Ltd. The device was registered on August 10, 2022.

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