QuickVue™
QuickVue™ Influenza+SARS Test Control Kit
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
Record
| Listed by | Wondfo USA Co., Ltd., United States |
|---|---|
| FDA product code | MJZ |
| Device type | Kit, Direct Antigen, Positive Control |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 30 °C |
| Packaging | Pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20519 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helix Elite™ Molecular Standards: Inactivated Standard | Microbiologics, Inc. | 1 |
| BinaxNOW® Malaria Positive Control Kit | Alere Scarborough, Inc. | 1 |
| WELLlife™ | Wondfo USA Co., Ltd. | 1 |
| QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit | Osang Healthcare Co., Ltd. | 1 |
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.