QuickFinder™ COVID-19/Flu Antigen Self Test RAUCC02ENA1

GUDID 08809115904423

2 Test / Kit

OSANG HEALTHCARE Co., Ltd.

SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical

• Primary Device ID: 08809115904423
• NIH Device Record Key: 25dbbdee-fd2c-42e6-b444-c42c7ccef9bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickFinder™ COVID-19/Flu Antigen Self Test
• Version Model Number: OI-01SU-CC
• Catalog Number: RAUCC02ENA1
• 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: false

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809115904423 [Primary]

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: 2024-05-20
• Device Publish Date: 2024-05-10

Devices Manufactured by OSANG HEALTHCARE Co., Ltd.

• 08809115903297 - OHC COVID-19/ Flu Antigen Test Pro: 2024-05-20 25 Test / Kit
• 08809115904423 - QuickFinder™ COVID-19/Flu Antigen Self Test: 2024-05-202 Test / Kit
• 08809115904423 - QuickFinder™ COVID-19/Flu Antigen Self Test: 2024-05-20 2 Test / Kit
• 08809115904119 - CURO L5 Glucose test strip: 2022-10-04 Glucose test strip(25T)
• 08809115904225 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 25 Test Kit / Box
• 08809115904232 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 5 Test Kit / Box
• 08809115904249 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 4 Test Kit / Box
• 08809115904256 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 2 Test Kit / Box
• 08809115904263 - QuickFinder COVID-19 Antigen Self Test: 2022-06-30 1 Test Kit / Box