QuickFinder™ COVID-19/Flu Antigen Self Test RCUCC01ENA1

GUDID 08809115900456

1 Test Kit / Box

OSANG HEALTHCARE Co., Ltd.

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 08809115900456
• NIH Device Record Key: 8e5cc704-d9ed-4702-9023-f895cb4914aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickFinder™ COVID-19/Flu Antigen Self Test
• Version Model Number: OI-01SU-CC
• Catalog Number: RCUCC01ENA1
• Company DUNS: 688195374
• Company Name: OSANG HEALTHCARE Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com
• Phone: 1-844-760-0556
• Email: covidhometest@osangllc.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809115900456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243262

FDA Product Code

• SCA: Multi-Analyte Respiratory Virus Antigen Detection Test

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-25
• Device Publish Date: 2025-03-17

On-Brand Devices [QuickFinder™ COVID-19/Flu Antigen Self Test]

• 08809115904423: 2 Test / Kit
• 08809115900456: 1 Test Kit / Box
• 08809115900449: 2 Test Kit / Box
• 08809115900432: 4 Test Kit / Box
• 08809115900425: 5 Test Kit / Box