Singapore HSA registration DE0506955
Abbott Diagnostics Scarborough ID NOW™ RSV
Singapore·CLASS C IVD·Abbott Diagnostics Scarborough, Inc.·Registered June 14, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506955
- Registration Date
- June 14, 2022
- Change Notification Approval Date
- November 18, 2024
- Retention Due Date
- June 13, 2025
Product description
The ID NOW™ RSV assay performed on the ID NOW™ Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection of respiratory syncytial virus (RSV) viral RNA in direct nasopharyngeal swabs and nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the diagnosis of RSV in children <18 years and adults ≥60 years in conjunction with clinical and epidemiological risk factors.
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)
- ID NOW™ RSV ID NOW™ RSV Control Swab Kit ID NOW™ Instrument ID NOW™ Instrument
- Model Identifier(s)
- 435-000 435-080 NAT-000 NAT-000S
About this record
Access comprehensive regulatory information for Abbott Diagnostics Scarborough ID NOW™ RSV 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 DE0506955 and owned by Abbott Diagnostics Scarborough, Inc.. The device was registered on June 14, 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