Singapore HSA registration DE0506916
Abbott Diagnostics Scarborough BinaxNOW Legionella Urinary Antigen Card
Singapore·CLASS C IVD·Abbott Diagnostics Scarborough, Inc.·Registered May 31, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506916
- Registration Date
- May 31, 2022
- 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 serogroup 1 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.
Product Owner
- Short Name
- Abbott Diagnostics Scarborough, Inc.
- Address
- 10 Southgate Road, Scarborough,, Maine 04074, UNITED STATES
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
- Model Name(s)
- BinaxNOW™ Legionella Urinary Antigen Card BinaxNOW™ Legionella Control Swab Pack
- Model Identifier(s)
- 852-000 852-010
About this record
Access comprehensive regulatory information for Abbott Diagnostics Scarborough BinaxNOW Legionella Urinary Antigen Card 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 DE0506916 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