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Singapore HSA registration DE0509498

Abbott Diagnostics Panbio™ COVID-19/Flu A&B Panel (Nasal)

Singapore flagSingapore·CLASS D IVD·Abbott Rapid Dx Galway·Registered July 05, 2024
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0509498
Registration Date
July 05, 2024
Retention Due Date
July 04, 2025
Product description
The Panbio™ CODVID-19/Flu A&B Panel (Nasal) is an in vitro diagnostic rapid test for the qualitative detection of nucleocapsid proteins SARS-CoV-2 and nucleoproteins Influenza A&B antigens (Ag) in human nasal mid-turbinate (NMT) swab specimens from symptomatic individuals, who meet COVID-19 and/or Influenza clinical and/or epidemiological criteria. Panbio™ COVID-19/Flu A&B Panel (Nasal) is intended for use by trained professionals in a laboratory and near-patient setting as an aid in the diagnosis of SARS-CoV-2 and Influenza infection. It is not intended for self-testing.
Product Owner
Name
Abbott Rapid Dx Galway
Short Name
Abbott Rapid Dx Galway
Address
Parkmore East Business Park, Ballybrit, Galway, IRELAND
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED DCH AURIGA SINGAPORE
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
Model Name(s)
Panbio COVID-19/Flu A&B Panel (Nasal) Panbio COVID-19/Flu A&B Panel (Nasal)
Model Identifier(s)
62FK31 62FK41
About this record

Access comprehensive regulatory information for Abbott Diagnostics Panbio™ COVID-19/Flu A&B Panel (Nasal) in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0509498 and owned by Abbott Rapid Dx Galway. The device was registered on July 05, 2024.

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 D IVD