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Singapore HSA registration DE0506917

Abbott Diagnostics Scarborough BinaxNOW™ Legionella Urinary Antigen Card System

Singapore flagSingapore·CLASS C IVD·Abbott Diagnostics Scarborough, Inc.·Registered May 31, 2022
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0506917
Registration Date
May 31, 2022
Change Notification Approval Date
August 19, 2024
Retention Due Date
May 30, 2025
Product description
BinaxNOW™ Legionella Urinary Antigen Card (BinaxNOW™ Legionella) is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection(Legionnaires’ Disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods. BinaxNOW™ Legionella Urinary Antigen card can be read visually or used in conjunction with the DIGIVAL™.
Product Owner
Name
Abbott Diagnostics Scarborough, Inc.
Short Name
Abbott Diagnostics Scarborough, Inc.
Address
10 Southgate Road, Scarborough,, Maine 04074, UNITED STATES
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
DCH AURIGA SINGAPORE
Address
10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
Model Name(s)
BinaxNOW™ Legionella Control Swab Pack BinaxNOW™ Legionella Urinary Antigen Card BinaxNOW™ Legionella Urinary Antigen Card DIGIVAL™ DIGIVAL™Calibration CheckCard Pack DIGIVAL™ Tray 1 Pack
Model Identifier(s)
852-010 852-012 852-100 LFR-000 LFR-003 LFR-004
About this record

Access comprehensive regulatory information for Abbott Diagnostics Scarborough BinaxNOW™ Legionella Urinary Antigen Card System 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 DE0506917 and owned by Abbott Diagnostics Scarborough, Inc.. The device was registered on May 31, 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 C IVD