Clungene RSV Antigen Rapid Test
FDA 510(k) K253318 · Hangzhou Clongene Biotech Co., Ltd.
510(k) numberK253318
Submission
- Device name
- Clungene RSV Antigen Rapid Test
- Applicant
- Hangzhou Clongene Biotech Co., Ltd.
Hangzhou, CN - Received
- September 30, 2025
- Decision date
- January 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GQG – Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
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|---|---|---|---|
| K240280 | Nano-Check RSV TestGQG · Dual Track | Nano-Ditech Corporation | 07/30/2024SE |
| K162911 | Sofia RSV FIA on Sofia 2 analyzerGQG · Traditional | Quidel Corporation | 02/22/2017SE |
| K133140 | BD Veritor System for the Rapid Detection of RSVGQG · Special | Becton, Dickinson & CO | 11/15/2013SE |
| K132456 | BD Veritor (TM) System for Rapid Detection of RSVGQG · Traditional | Becton, Dickinson and Company | 11/07/2013SE |
| K130398 | Sofia(R) RSV FiaGQG · Traditional | Quidel Corp. | 08/13/2013SE |
| K121633 | BD Veritor(Tm) System for the Rapid Detection of RSVGQG · Traditional | Becton, Dickinson and Company | 09/18/2012SE |
| K101918 | Quickvue RSV 10GQG · Traditional | Quidel Corp. | 09/24/2010SE |
| K101514 | BD Directigen Ez RSVGQG · Traditional | Becton, Dickinson & CO | 07/09/2010SE |
| K091235 | Ramp RSV AssayGQG · Traditional | Response Biomedical Corp. | 07/24/2009SE |
| K070747 | Quick Vue RSV Test, Models 20193, 20199GQG · Traditional | Quidel Corp. | 04/23/2007SE |
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Questions and answers
When was Clungene RSV Antigen Rapid Test cleared by the FDA?
Clungene RSV Antigen Rapid Test (K253318) received a 510(k) decision of Substantially Equivalent on January 30, 2026, 122 days after the submission was received.
What is the product code of K253318?
The FDA product code is GQG – Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, a Class I (low risk) device regulated under 21 CFR 866.3480.