GQG
- Product code
- GQG
- Device name
- Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device class
- Class 1
- 21 CFR
- 21 CFR 866.3480
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 32 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253318 | 2026-01-30 | Hangzhou Clongene Biotech Co., Ltd. | Clungene RSV Antigen Rapid Test | FDA |
| K240280 | 2024-07-30 | Nano-Ditech Corporation | Nano-Check RSV Test | FDA |
Official FDA classification page: GQG
Classification and pathway per current FDA publications. Data from openFDA (CC0).