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Singapore HSA registration DE0508239

Abbott Rapid Diagnostics Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)

Singapore flagSingapore·CLASS D IVD·Abbott Rapid Diagnostics Jena GmbH·Registered June 26, 2023
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0508239
Registration Date
June 26, 2023
Retention Due Date
June 25, 2025
Product description
Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. Panbio™ COVID-19 Ag Rapid Test Device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a donor screening test for SARS-CoV-2.
Product Owner
Name
Abbott Rapid Diagnostics Jena GmbH
Short Name
Abbott Rapid Diagnostics Jena GmbH
Address
Orlaweg 1, 07743 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 Ag Rapid Test Device (Nasopharyngeal) Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)
Model Identifier(s)
41FK10 41FK20
About this record

Access comprehensive regulatory information for Abbott Rapid Diagnostics Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal) 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 DE0508239 and owned by Abbott Rapid Diagnostics Jena GmbH. The device was registered on June 26, 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