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Singapore HSA registration DE0508931

Cell Marque MUC2 (MRQ-18) Mouse Monoclonal Antibody

Singapore flagSingapore·CLASS B IVD·Cell Marque Corporation·Registered February 06, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Pathology
Registration information
Registration Number
DE0508931
Registration Date
February 06, 2024
Change Notification Approval Date
February 04, 2025
Retention Due Date
February 05, 2026
Product description
MUC2 (MRQ-18) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the MUC2 protein in formalin-fixed, paraffin-embedded tissue stained on VENTANA BenchMark IHC/ISH instruments. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is 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)
MUC2 (MRQ-18) Mouse Monoclonal Antibody
Model Identifier(s)
760-4388 / 05463556001
About this record

Access comprehensive regulatory information for Cell Marque MUC2 (MRQ-18) Mouse Monoclonal Antibody 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 DE0508931 and owned by Cell Marque Corporation. The device was registered on February 06, 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