Singapore HSA registration DE0506889
Abbott Rapid Diagnostics Panbio™ COVID-19 Ag Rapid Test Device (Nasal)
Singapore·CLASS D IVD·Abbott Rapid Diagnostics Jena GmbH·Registered May 25, 2022Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506889
- Registration Date
- May 25, 2022
- Change Notification Approval Date
- September 02, 2024
- Retention Due Date
- May 24, 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 nasal 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
- Short Name
- Abbott Rapid Diagnostics Jena GmbH
- Address
- Orlaweg 1, 07743 Jena, GERMANY
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- 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 Ag Rapid Test Device (Nasal) Panbio™ COVID-19 Ag Rapid Test Device Positive Control Kit Panbio™ COVID-19 Ag Rapid Test Device (Nasal)
- Model Identifier(s)
- 41FK11 41FK11CON 41FK21
About this record
Access comprehensive regulatory information for Abbott Rapid Diagnostics Panbio™ COVID-19 Ag Rapid Test Device (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 DE0506889 and owned by Abbott Rapid Diagnostics Jena GmbH. The device was registered on May 25, 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 D IVD