Clungene
The Clungene test is a lateral-flow immunoassay for qualitative detection of RSV nucleoprotein antigen in nasopharyngeal swab specimens. Its intended-use statement describes samples from…
The Clungene test is a lateral-flow immunoassay for qualitative detection of RSV nucleoprotein antigen in nasopharyngeal swab specimens.
Its intended-use statement describes samples from patients with signs and symptoms of respiratory infection and use as an aid in RSV diagnosis.
Result Interpretation
The filing says a negative result does not rule out RSV and should not be the sole basis for treatment or patient-management decisions. The filing identifies this as an in vitro diagnostic test.
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 | Hangzhou Clongene Biotech Co., Ltd., China |
|---|---|
| FDA product code | GQG |
| Device type | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3480 |
| Establishment | Manufacturer |
| 510(k) | K253318 |
| Record published | 2026-04-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IRSVq008-201612 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BinaxNOW RSV | Alere Scarborough, Inc. | 4 |
| 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 |
Showing 12 of 20. All products under Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253318 | 2026-01-30 |
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.