A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relati
| Company | Devices | Share |
|---|---|---|
| Wondfo Usa Co., Ltd. | 20 | 21% |
| Ihealth Labs Inc. | 18 | 19% |
| Alere Scarborough, Inc. | 18 | 19% |
| Access Bio Inc. | 5 | 5% |
| Mckesson Medical-Surgical Inc. | 5 | 5% |
| Osang Healthcare Co., Ltd. | 4 | 4% |
| Confirm Biosciences, Inc. | 3 | 3% |
| Healgen Scientific Limited Liability Company | 3 | 3% |
| Walgreen Co. | 3 | 3% |
| Woonsocket Prescription Center, Incorporated | 3 | 3% |
| Btnx Inc | 3 | 3% |
| Genabio Diagnostics Inc. | 2 | 2% |
Company = labeler of record on GUDID. 18 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 |
|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 83 |
| QMN | Covid-19 Multi-Analyte Antigen Device | 6 |
| SCA | Multi-analyte respiratory virus antigen detection test | 2 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Vi | 2 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 2 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
95 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing", from 18 companies. The largest labeler is Wondfo Usa Co., Ltd. with 21% of records.
SCA (Multi-Analyte Respiratory Virus Antigen Detection Test), QMN (Covid-19 Multi-Analyte Antigen Device), SCA (Multi-analyte respiratory virus antigen detection test), QVF (Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Vi)
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.