Listed Rapid Antigen Tests for Influenza under MDACS
The following rapid antigen tests for Influenza have been listed under the Medical Device Division (MDD). All the listed devices meet the listing requirements of Medical Device Administrative Control System (MDACS) on safety, quality and performance.
Details of listed rapid antigen tests for Influenza can be found in The List of Medical Devices.
Table 1: Combination rapid antigen tests for Influenza and other pathogens that are intended for use to differentiate viral infection(s)
# Disclaimer: Package photos of the products are the latest ones submitted by the Local Responsible Person for listing under Medical Device Administrative Control System.
| Listing No. (HKMD No.) |
Manufacturer | Brand Name and Model | Intended User | Local Responsible Person | Package # |
|---|---|---|---|---|---|
| 230160 | Hangzhou AllTest Biotech Co., Ltd. | SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (ISIN-525H) | Self-use | Dynamiker Biotechnology (Hong Kong) Company Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 Package 9 Package 10 Package 11 Package 12 Package 13 Package 14 |
| 230344 | Hangzhou Heo Technology Co., Ltd. | Heo Technology, COVID-19/lnfluenza A+B Antigen Combo Rapid Test Cassette (010027, 010028) | Self-use | AccuMed Limited |
Package 1 Package 2 |
| 230452 | Hangzhou Realy Tech Co., Ltd. | SARS-Cov-2 & Influenza A/B Combo Rapid Test Cassette (swab) (K751416D) | Self-use | Sincere Top International Limited |
Package 1 Package 2 Package 3 |
| 240133 | Hangzhou Fanttest Biotech Co., Ltd. | COVID-19/Influenza A&B Antigen Test Kit (1 Test/Kit, 5 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit) | Self-use | Top Biological Technology Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 |
| 240148 | Jiangsu Medomics Medical Technology Co. Ltd | Medomics SARS Cov-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) (1041-14-01, 1041-24-01, 1041-34-01, 1041-54-01) | Self-use | Million Source Limited |
Package 1 Package 2 Package 3 Package 4 |
| 240333 | Hangzhou Fanttest Biotech Co., Ltd. | Fanttest COVID-19/RSV/Influenza A&B Antigen Rapid Test Kit (1 Test/Kit, 5 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit) | Self-use | Top Biological Technology Limited |
Package 1 Package 2 Package 3 Package 4 |
| 240334 | Hangzhou Fanttest Biotech Co., Ltd. | Diagfest COVID-19/RSV/Influenza A&B Antigen Rapid Test Kit (1 Test/Kit, 5 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit) | Self-use | Top Biological Technology Limited |
Package 1 Package 2 Package 3 Package 4 |
| 240361 | Hangzhou Fanttest Biotech Co., Ltd. | Fanttest COVID-19/RSV/Influenza A&B Antigen Rapid Test Kit (1 Test/Kit, 5 Tests/Kit) | Self-use | AccuMed Limited |
Package 1 Package 2 Package 3 Package 4 |
| 230024 | Xiamen Hopegen Medical Technology Co., Ltd | COVID-19 / influenza A virus / influenza B virus Antigen test kit (colloidal gold) (1 test/kit) | Healthcare professional use only | Top Empire International Limited |
Package 1 Package 2 |
| 241165 | Hangzhou Fanttest Biotech Co., Ltd. | Fanttest SARS-CoV-2/RSV/Adenovirus/ Influenza A+B Antigen Combo Rapid Test Kit (25 Tests/Kit) | Healthcare professional use only | AccuMed Limited |
Package 1 |
| 241437 | SD Biosensor, Inc. | Standard Q Covid/Flu Ag Combo Test (Q-CVFL-01C) | Healthcare professional use only | POTUS Medical (Hong Kong) Limited |
Package 1 |
| 250229 | Beijing Kewei Clinical Diagnostic Reagent Inc. | SARS-COV-2/FluA/FluB Antigen Combo Rapid Test Kit | Healthcare professional use only | AUISET Health Limited |
Package 1 Package 2 Package 3 |
| 250237 | Hangzhou Fanttest Biotech Co., Ltd. | Fanttest SARS-CoV-2/RSV/Adenovirus/ Influenza A+B Antigen Combo Rapid Test Kit (1 Test/Kit, 5 Tests/Kit, 25 Tests/Kit) | Healthcare professional use only | Top Biological Technology Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 |
| 250242 | Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. | EZER SARS-CoV-2 & Flu & RSV & ADV Antigen Combo Rapid Test | Healthcare professional use only | BioArrow Technology Limited |
Package 1 Package 2 |
| 250274 | Hangzhou Fanttest Biotech Co., Ltd. | Fanttest SARS-CoV-2/RSV/Adenovirus/ M.pneumoniae/ Influenza A+B Antigen Combo Rapid Test Kit (1 test/kit, 5 tests/kit, 25 tests/kit) | Healthcare professional use only | Top Biological Technology Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 |
| 250336 | Phase Scientific International Limited | INDICAID Covid-19/Flu A&B Rapid Antigen Test (12 tests, 24 tests) | Healthcare professional use only | Phase Scientific International Limited |
Package 1 Package 2 |
| 250344 | Phase Scientific International Limited | INDICAID Respiratory 6-in-1 Rapid Antigen Test (12 tests, 24 tests) | Healthcare professional use only | Phase Scientific International Limited |
Package 1 Package 2 |
| 250357 | Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. | EZER Flu & COVID-19 Antigen Duo Rapid Test (P213106) | Self-use | BioArrow Technology Limited |
Package 1 |
| 250607 | Abbott Rapid Dx Galway | Panbio COVID-19/Flu A&B Panel Self Test (62FK51, 62FK71, 62FK81, 62FK91) | Self-use | Abbott Laboratories Limited |
Package 1 Package 2 Package 3 Package 4 |
| 250608 | Abbott Rapid Dx Galway | Panbio COVID-19/Flu A&B Panel (Nasal) (62FK31, 62FK41) | Healthcare professional use only | Abbott Laboratories Limited |
Package 1 Package 2 |
Users should carefully read the instructions for use provided by the manufacturer of the combination rapid antigen tests when interpret the result and should seek help from medical practitioners when necessary.
Table 2: Rapid antigen tests for Influenza only
# Disclaimer: Package photos of the products are the latest ones submitted by the Local Responsible Person for listing under Medical Device Administrative Control System.
| Listing No. (HKMD No.) |
Manufacturer | Brand Name and Model | Intended User | Local Responsible Person | Package # |
|---|---|---|---|---|---|
| 240331 | Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. | EZER Flu A+B Antigen Rapid Test (P211002) | Healthcare professional use only | BioArrow Technology Limited | Package 1 |
| 250346 | SD Biosensor, Inc. | STANDARD F Influenza A/B FIA (FINF01G) | Healthcare professional use only | POTUS Medical (Hong Kong) Limited | Package 1 |
Last update on 6 March 2025
