Singapore HSA registration DE0506954
Abbott Diagnostics Scarborough ID NOW™ Strep A 2
Singapore·CLASS B IVD·Abbott Diagnostics Scarborough, Inc.·Registered June 14, 2022Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506954
- Registration Date
- June 14, 2022
- Change Notification Approval Date
- December 10, 2024
- Retention Due Date
- June 13, 2025
Product description
ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.
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™ Strep A2 ID NOW™ Strep A2 Control Swab Kit ID NOW™ Instrument
- Model Identifier(s)
- 734-000 734-080 NAT-000
About this record
Access comprehensive regulatory information for Abbott Diagnostics Scarborough ID NOW™ Strep A 2 in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506954 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 B IVD