A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus di
| Company | Devices | Share |
|---|---|---|
| Alere Scarborough, Inc. | 18 | 13% |
| Wondfo Usa Co., Ltd. | 17 | 12% |
| Coretests, Inc. | 15 | 11% |
| Osang Healthcare Co., Ltd. | 10 | 7% |
| Xiamen Boson Biotech Co., Ltd. | 9 | 7% |
| Genabio Diagnostics Inc. | 8 | 6% |
| Beijing Hotgen Biotech Co., Ltd. | 6 | 4% |
| Bioteke Usa, Llc | 6 | 4% |
| Ihealth Labs Inc. | 5 | 4% |
| Genbody Inc. | 5 | 4% |
| Phase Scientific International Limited | 4 | 3% |
| Access Bio Inc. | 4 | 3% |
Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| QKP | Coronavirus Antigen Detection Test System. | 76 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 40 |
| QMN | Covid-19 Multi-Analyte Antigen Device | 8 |
| QYT | Over-the-Counter COVID-19 Antigen Test | 3 |
| QKP | Coronavirus antigen detection test system. | 3 |
| QLW | Covid-19 Test Home Collection Kit Devices | 1 |
Use these as the dimensions to specify in a tender line.
138 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing", from 26 companies. The largest labeler is Alere Scarborough, Inc. with 13% of records.
QKP (Coronavirus Antigen Detection Test System.), QYT (Over-The-Counter Covid-19 Antigen Test), QMN (Covid-19 Multi-Analyte Antigen Device), QYT (Over-the-Counter COVID-19 Antigen Test)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.