CLUNGENE

Basic Information

• Brand Name: CLUNGENE
• Primary DI: 06950921308096
• Version / Model: IRSVq008-201612
• Company Name: Hangzhou Clongene Biotech Co., Ltd.
• Labeler DUNS: 724157438
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-11
• Public Version: 1
• Public Version Date: 2026-04-20
• Public Version Status: New
• Public Device Record Key: 43f65b58-79b3-477b-a44d-d869bcfe7bd9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	866.3480	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49500	Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from respiratory syncytial virus (RSV) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06950921308096	GS1

Premarket Submissions

Submission Number	Supplement Number
K253318	000