Pure Global
Singapore HSA registration DE0506944

Abbott Diagnostics Scarborough BinaxNOW™ Streptococcus pneumoniae Antigen card System

Singapore flagSingapore·CLASS C IVD·Abbott Diagnostics Scarborough, Inc.·Registered June 08, 2022
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0506944
Registration Date
June 08, 2022
Change Notification Approval Date
August 19, 2024
Retention Due Date
June 07, 2025
Product description
The BinaxNOW™ Streptococcus pneumoniae Antigen Card (BinaxNOW™ Streptococcus pneumoniae) is an in vitro rapid immunochromatographic (ICT) assay for the detection of Streptococcus pneumoniae (S. pneumoniae) antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. It is intended, in conjunction with culture and other methods, to aid in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis. The BinaxNOW™ S. pneumoniae Antigen Card can be read visually or used in conjunction with the DIGIVAL™ Reader.
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™ Streptococcus pneumoniae Control Swab Pack BinaxNOW™ Streptococcus pneumoniae Antigen Card BinaxNOW™ Streptococcus pneumoniae Antigen Card DIGIVAL™ DIGIVAL™ Calibration Check Card Pack DIGIVAL™ Tray 1 Pack
Model Identifier(s)
710-010 710-012 710-100 LFR-000 LFR-003 LFR-004
About this record

Access comprehensive regulatory information for Abbott Diagnostics Scarborough BinaxNOW™ Streptococcus pneumoniae 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 DE0506944 and owned by Abbott Diagnostics Scarborough, Inc.. The device was registered on June 08, 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