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Singapore HSA registration DE0506690

Abbott Alinity s Anti-HCV II

Singapore flagSingapore·CLASS D IVD·Abbott GmbH·Registered March 03, 2022
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0506690
Registration Date
March 03, 2022
Change Notification Approval Date
July 04, 2024
Retention Due Date
March 02, 2026
Product description
The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma, including specimens collected postmortem (non-heart-beating), on the Alinity s System. The Alinity s Anti-HCV II assay is intended to be used as an aid in the diagnosis of HCV infection and as a screening test to prevent transmission of HCV to recipients of blood, blood components, cells, tissues, and organs.
Product Owner
Name
Abbott GmbH
Short Name
Abbott GmbH
Address
Max-Planck-Ring 2, 65205 Wiesbaden, GERMANY
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
Model Name(s)
Alinity s Anti-HCV II Assay File Alinity s Anti-HCV II Calibrator Kit Alinity s Anti-HCV II Assay Control Kit Alinity s Anti-HCV II Release Control Kit Alinity s Anti-HCV II Reagent Kit Alinity s Anti-HCV II Reagent Kit
Model Identifier(s)
04W56-1D 04W5602 04W5610 04W5612 04W5655 04W5656
About this record

Access comprehensive regulatory information for Abbott Alinity s Anti-HCV II in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0506690 and owned by Abbott GmbH. The device was registered on March 03, 2022.

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 D IVD