Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Clungene RSV Antigen Rapid Test

K-Number: K253318 · 2026-01-30

ApplicantHangzhou Clongene Biotech Co., Ltd.
Decision Date2026-01-30
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Clungene RSV Antigen Rapid Test is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under approval number K253318. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clungene RSV Antigen Rapid Test?

Clungene RSV Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2026-01-30. It is manufactured by Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K253318.

When was Clungene RSV Antigen Rapid Test approved by the FDA?

Clungene RSV Antigen Rapid Test received FDA 510(k) clearance on 2026-01-30, under approval number K253318.

What company makes Clungene RSV Antigen Rapid Test?

Clungene RSV Antigen Rapid Test is manufactured by Hangzhou Clongene Biotech Co., Ltd..

What is the FDA product code for Clungene RSV Antigen Rapid Test?

The FDA product code for Clungene RSV Antigen Rapid Test is GQG.

Other Devices by Hangzhou Clongene Biotech Co., Ltd.

K161251CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K180255CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

View all 9 devices →

Related Devices (Code: GQG)

K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation K240280Nano-Check™ RSV TestNano-Ditech Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑