HSA · registration DE0509498Abbott Diagnostics Panbio™ COVID-19/Flu A&B Panel (Nasal)
- Registration number
- DE0509498
- Model name
- Panbio COVID-19/Flu A&B Panel (Nasal); Panbio™ COVID-19/Flu A&B Panel Positive Controls; Panbio COVID-19/Flu A&B Panel (Nasal)
- Model identifier
- 62FK31; 62FK31CON; 62FK41
- Registration date
- July 05, 2024
- Source update date
- May 06, 2026
- Risk class
- Class D
- Product owner
- Abbott Rapid Dx Galway
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
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 address
- Parkmore East Business Park, Ballybrit, Galway, Ireland
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.