RDS
RSV Test Kit US Version 135060
4manufacturers in China registered for this device type
2catalogue 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 | American Bio Medica Corp., 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) | K021789 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
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 59 to 86 °F; Handling environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10-RSV-065 | 20 | In distribution | |
| 10-RSV-060 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BinaxNOW RSV | Alere Scarborough, Inc. | 4 |
| 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
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.