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Abbott Vysis CLL FISH Probe Kit - HSA Registration DE0501145

Access comprehensive regulatory information for Abbott Vysis CLL FISH Probe Kit 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 DE0501145 and owned by Abbott Molecular Inc. The device was registered on January 24, 2018.

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 C IVD
DE0501145
Abbott Vysis CLL FISH Probe Kit
HSA Registration Number: DE0501145
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Product Description

The Vysis CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence via fluorescence in situ hybridization (FISH) in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0501145
Registration Date
January 24, 2018
Retention Due Date
January 23, 2026
Product Owner
Short Name
Abbott Molecular Inc
Address
1300 E. Touhy Avenue, Des Plaines, IL 60018, 224-361-7000, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Vysis CLL FISH Probe Kit
Model Identifier(s)
04N02-21