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Ventana FITC Anti-IgA Primary Antibody - HSA Registration DE0509386

Access comprehensive regulatory information for Ventana FITC Anti-IgA 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 DE0509386 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.

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CLASS B IVD
DE0509386
Ventana FITC Anti-IgA Primary Antibody
HSA Registration Number: DE0509386
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Product Description

FITC Anti-IgA Primary Antibody is a polyclonal antibody labeled with fluorescein. It is intended for laboratory use in the qualitative immunofluorescent detection of IgA 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.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Pathology
Registration Information
Registration Number
DE0509386
Registration Date
June 12, 2024
Retention Due Date
June 11, 2026
Product Owner
Short Name
Ventana Medical Systems, Inc.
Address
1910 East Innovation Park Drive, Tucson, AZ, 85755, UNITED STATES
Registrant
Address
8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
Address
8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model Information
Model Name(s)
FITC Anti-IgA Primary Antibody
Model Identifier(s)
760-2681 / 05267927001