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Singapore HSA registration DE0510033

Cell Marque HHV-8(13B10) Mouse Monoclonal Antibody

Singapore flagSingapore·CLASS C IVD·Cell Marque Corporation·Registered November 11, 2024
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Pathology
Registration information
Registration Number
DE0510033
Registration Date
November 11, 2024
Retention Due Date
November 10, 2025
Product description
HHV-8 Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the HHV-8 protein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) on 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)
HHV-8(13B10) Mouse Monoclonal Antibody
Model Identifier(s)
760-4260 / 05269229001
About this record

Access comprehensive regulatory information for Cell Marque HHV-8(13B10) Mouse Monoclonal Antibody 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 DE0510033 and owned by Cell Marque Corporation. The device was registered on November 11, 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 C IVD