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Abbott Diagnostics Scarborough ID NOW™ Strep A 2 - HSA Registration DE0506954

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.

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CLASS B IVD
DE0506954
Abbott Diagnostics Scarborough ID NOW™ Strep A 2
HSA Registration Number: DE0506954
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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.

Device 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 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