GenBody COVID-19 Ag COVAG025-U

GUDID 08800076700437

Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Emergency use of this test is limited to authorized laboratories.

Genbody Inc.

SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 08800076700437
• NIH Device Record Key: 9b52759b-14ce-43ac-b456-00eb8610ead4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenBody COVID-19 Ag
• Version Model Number: COVAG025-U
• Catalog Number: COVAG025-U
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@genbody.co.kr
• Phone: +821062090401
• Email: jychoi@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800076700437 [Primary]
GS1	08800076700475 [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: 2021-08-26
• Device Publish Date: 2021-08-18

On-Brand Devices [GenBody COVID-19 Ag]

• 08800076700437: Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal sw
• 08800076700499: Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab sp
• 08800076700772: Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab sp