Singapore HSA registration DE0501145
Abbott Vysis CLL FISH Probe Kit
Singapore·CLASS C IVD·Abbott Molecular Inc·Registered January 24, 2018Device 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 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).
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD