BinaxNOW® Malaria Positive Control Kit
The BinaxNOW® Malaria Positive Control.
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 | Alere Scarborough, Inc., United States |
|---|---|
| FDA product code | MJZ |
| Device type | Kit, Direct Antigen, Positive Control |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| 510(k) | K083744 |
| Record published | 2016-09-03 |
| Record revised | 2023-09-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 665-010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helix Elite™ Molecular Standards: Inactivated Standard | Microbiologics, Inc. | 1 |
| QuickVue™ | Wondfo USA Co., Ltd. | 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.