Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
The COVID-19/Flu A&B Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of COVID-19, Influenza A&B Antigen in Nasal swab. It is intended to aid in the rapid…
The COVID-19/Flu A&B Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of COVID-19, Influenza A&B Antigen in Nasal swab. It is intended to aid in the rapid differential diagnosis of COVID-19,Influenza A and B
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
Record
| Listed by | Zhengzhou Shiyi Biotech Co., Ltd. |
|---|---|
| FDA product code | GNX |
| Device type | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3330 |
| Premarket notification | Exempt |
| Record published | 2025-01-28 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 100, pack of 150 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A003 | 5 | In distribution | |
| A002 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuickVue | Quidel Corp. | 3 |
| Status Flu A+B card | Princeton BioMeditech Corp. | 3 |
| BioSign Flu A+B card | Princeton BioMeditech Corp. | 3 |
| Poly stat | Polymedco, Inc. | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Sofia | Quidel Corp. | 2 |
| OraSure Quick Flu 22-Count Flu A + B Kit | Orasure Technologies, Inc. | 1 |
| BD Veritor™ Plus Laboratory Combo Pack | Becton, Dickinson AND Company | 1 |
| Status Flu A+B Nasal Wash/Aspirate Kit | Princeton BioMeditech Corp. | 1 |
| Status Flu A & B | Princeton BioMeditech Corp. | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
| OraSure Quickflu Nasopharyngeal Wash / Aspirate | Orasure Technologies, Inc. | 1 |
Showing 12 of 22. All products under Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.