GenBody COVID-19 Ag Home Test COVAGHT2-U-25

GUDID 08800076700765

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.

Genbody Inc.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 08800076700765
• NIH Device Record Key: 974e2928-7f61-41a7-966e-4a7fab56972a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenBody COVID-19 Ag Home Test
• Version Model Number: COVAGHT2-U-25
• Catalog Number: COVAGHT2-U-25
• Company DUNS: 689451998
• Company Name: Genbody Inc.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr
• Phone: +825238990
• Email: hylee@genbody.co.kr

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800076700598 [Primary]
GS1	08800076700765 [Unit of Use]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

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: 2023-03-07
• Device Publish Date: 2023-02-27

On-Brand Devices [GenBody COVID-19 Ag Home Test]

• 08800076700734: Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the
• 08800076700758: Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the
• 08800076700765: Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the
• 08800076700741: Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the