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Singapore HSA registration DE0509389

Ventana FITC Anti-Fibrinogen Primary Antibody

Singapore flagSingapore·CLASS B IVD·Ventana Medical Systems, Inc.·Registered June 12, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Pathology
Registration information
Registration Number
DE0509389
Registration Date
June 12, 2024
Retention Due Date
June 11, 2026
Product description
FITC Anti-Fibrinogen Primary Antibody is a polyclonal antibody labeled with fluorescein. It is intended for laboratory use in the qualitative immunofluorescent detection of fibrinogen by fluorescence microscopy in sections of frozen tissue stained on a BenchMark IHC/ISH instrument. 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
Ventana Medical Systems, Inc.
Short Name
Ventana Medical Systems, Inc.
Address
1910 East Innovation Park Drive, Tucson, AZ, 85755, 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)
FITC Anti-Fibrinogen Primary Antibody
Model Identifier(s)
760-2685 / 05267960001
About this record

Access comprehensive regulatory information for Ventana FITC Anti-Fibrinogen Primary 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 DE0509389 and owned by Ventana Medical Systems, Inc.. The device was registered on June 12, 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