BinaxNOW RSV
A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash and nasopharyngeal swab specimens.
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 21 |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 21 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 |
Record
| Listed by | Alere Scarborough, Inc., United States |
|---|---|
| FDA product code | GQG |
| Device type | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3480 |
| 510(k) | K032166 |
| Record published | 2020-09-16 |
| Record revised | 2023-09-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 430-022 | In distribution | |
| 430-122 | In distribution | |
| 430-000 | In distribution | |
| 430-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RDS | American Bio Medica Corp. | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Sofia | Quidel Corp. | 2 |
| Rapid Response | Btnx Inc. | 2 |
| Chorus Respiratory Syncytial Virus IgG | Diesse Diagnostica Senese SPA | 1 |
| FLU/RSV Positive Control | Meridian Bioscience, Inc. | 1 |
| Red Tunica | Rodimedi & Associates Inc. | 1 |
| TRU RSV | Meridian Bioscience, Inc. | 1 |
| Nano-Check RSV Test | Nano-Ditech Corporation | 1 |
| Osom RSV Test | Sekisui Diagnostics, LLC | 1 |
| Ramp® RSV Test KIT; 25 Tests | Response Biomedical Corp. | 1 |
| Ramp® RSV Control Swabs | Response Biomedical Corp. | 1 |
Showing 12 of 20. All products under Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Diagnostics Scarborough, Inc. | 510(k) number | 2007-03-28 | Not classified | Other | Tip of the foam swab could detach from the shaft causing injury to the patient. | 2851 kits | 2008-09-08 |
| Abbott Diagnostics Scarborough, Inc. | 510(k) number | 2004-02-18 | Not classified | Other | Pouch integrity compromised | 667 kits | 2004-08-09 |
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.