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Abbott Vysis FISH Probe Kits (Genetic Testing) - HSA Registration DE0014166

Access comprehensive regulatory information for Abbott Vysis FISH Probe Kits (Genetic Testing) 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 DE0014166 and owned by Abbott Molecular Inc. The device was registered on October 28, 2013.

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
DE0014166
Abbott Vysis FISH Probe Kits (Genetic Testing)
HSA Registration Number: DE0014166
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Product Description

The Fluorescence In Situ Hybridization (FISH) probes intended to detect and localize the presence or absence of specific DNA sequences on chromosomes, and for use in human genetic testing.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Pathology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0014166
Registration Date
October 28, 2013
Change Notification Approval Date
January 02, 2014
Retention Due Date
October 27, 2025
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 SRY/CEP X FISH Probe Kit
Model Identifier(s)
06N29-020