Genbody Inc.

Address:3-18, Eopseong 2-gil, Cheonan-si,Chungnam,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Coronavirus Antigen Detection Test System. (QKP) (2)

Premarket Exempt

Yes

Clear

GenBody COVID-19 Ag - 08800076700437 Catalog Number : COVAG025-U

Device Description : Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct n 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.

Device Class :

Duns Number: 689451998

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : Yes

Device Count : 25

GenBody COVID-19 Ag - 08800076700482 Catalog Number : COVAG025-NU

Device Description : Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior na Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. For use under an emergency use authorization (EUA) only.