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Singapore HSA registration DE0508929

Cell Marque Immunohistochemistry Antibody (Hematologic Disorder and Blood Cancer Markers )

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
DE0508929
Registration Date
February 06, 2024
Change Notification Approval Date
December 30, 2024
Retention Due Date
February 05, 2026
Product description
These antibodies are intended for laboratory use in formalin-fixed, paraffin-embedded tissue stained on VENTANA 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)
CD57 (NK-1) Mouse Monoclonal Antibody CD21 (2G9) Mouse Monoclonal Antibody CD45 (LCA) (2B11 & PD7/26) Mouse Monoclonal Antibody Granzyme B Rabbit Polyclonal Antibody CD25 (4C9) Mouse Monoclonal Antibody Oct-2 (MRQ-2) Mouse Monoclonal Antibody BOB.1 (SP92) Rabbit Monoclonal Antibody
Model Identifier(s)
760-2626 / 05267366001 760-4245 / 05269059001 760-4279 / 05269423001 760-4283 / 05269466001 760-4439 / 05973899001 760-4447 / 05973791001 760-4593 / 06433308001
About this record

Access comprehensive regulatory information for Cell Marque Immunohistochemistry Antibody (Hematologic Disorder and Blood 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 DE0508929 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