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Singapore HSA registration DE0508190

Abbott Rapid Diagnostics Panbio™ COVID-19 Antigen Self-Test

Singapore flagSingapore·CLASS D IVD·Abbott Rapid Diagnostics Jena GmbH·Registered June 14, 2023
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0508190
Registration Date
June 14, 2023
Retention Due Date
June 13, 2025
Product description
The Panbio™ COVID-19 Antigen Self-Test is a single-use, in vitro (outside the body) visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen (Ag). The Panbio™ COVID-19 Antigen Self-Test is intended to be used manually by untrained lay users (self testing) in a private setting to aid in the diagnosis of an active SARS-CoV-2 infection. Children under 14 years should be supported by an adult.
Product Owner
Name
Abbott Rapid Diagnostics Jena GmbH
Short Name
Abbott Rapid Diagnostics Jena GmbH
Address
Orlaweg 1, 07743 Jena, Jena, GERMANY
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
DCH AURIGA SINGAPORE
Address
10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
Model Name(s)
Panbio™ COVID-19 Antigen Self-Test Panbio™ COVID-19 Antigen Self-Test Panbio™ COVID-19 Antigen Self-Test Panbio™ COVID-19 Antigen Self-Test
Model Identifier(s)
41FK51 41FK71 41FK81 41FK91
About this record

Access comprehensive regulatory information for Abbott Rapid Diagnostics Panbio™ COVID-19 Antigen Self-Test 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 DE0508190 and owned by Abbott Rapid Diagnostics Jena GmbH. The device was registered on June 14, 2023.

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