Duns Number:689451998
Device Description: Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) s 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.
Catalog Number
COVAG025-NU
Brand Name
GenBody COVID-19 Ag
Version/Model Number
COVAG025-NU
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QKP
Product Code Name
Coronavirus Antigen Detection Test System.
Public Device Record Key
1774f5b1-9ac5-400c-a3d7-f7ea851acc67
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 19, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-