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Singapore HSA registration DE0509281

Cell Marque Immunohistochemistry Antibody ( Other Cancer Markers )

Singapore flagSingapore·CLASS B IVD·Cell Marque Corporation·Registered May 10, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Pathology
Registration information
Registration Number
DE0509281
Registration Date
May 10, 2024
Retention Due Date
May 09, 2026
Product description
These antibodies are intended for laboratory use in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) on BenchMark IHC/ISH instruments. These products should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. These antibodies are intended for in vitro diagnostic (IVD) use.
Product Owner
Name
Cell Marque Corporation
Short Name
Cell Marque Corporation
Address
6600 Sierra College Blvd., Rocklin, CA 95677, UNITED STATES
Registrant
Name
Roche Diagnostics Asia Pacific Pte Ltd
Address
8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
Name
Roche Diagnostics Asia Pacific Pte Ltd
Address
8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model information
Model Name(s)
Gastrin Rabbit Polyclonal Antibody TSH Rabbit Polyclonal Antibody
Model Identifier(s)
760-2643 / 05267536001 760-2709 / 05268184001
About this record

Access comprehensive regulatory information for Cell Marque 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 DE0509281 and owned by Cell Marque Corporation. The device was registered on May 10, 2024.

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