QuickFinder™ COVID-19/Flu Antigen Self Test

Basic Information

• Brand Name: QuickFinder™ COVID-19/Flu Antigen Self Test
• Primary DI: 08809115900432
• Version / Model: OI-01SU-CC
• Catalog Number: RCUCC04ENA1
• Company Name: OSANG HEALTHCARE Co., Ltd.
• Labeler DUNS: 688195374
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-18
• Public Version: 1
• Public Version Date: 2025-03-26
• Public Version Status: New
• Public Device Record Key: c66eead3-ae29-474c-ada2-e22a835aaafe

Device Description

4 Test Kit / Box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	866.3987	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66040	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809115900432	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243262	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit