Duns Number:527409818
Device Description: Non-prescription home use for the qualitative detection of nucleocapsid protein antigen fr Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Catalog Number
-
Brand Name
Boson - Rapid SARS-CoV-2 Antigen Test Card - 20 Tests/Kit
Version/Model Number
1N40C5-20-US
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
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
190a0336-e53e-4003-bf57-7dbd754057e4
Public Version Date
October 17, 2022
Public Version Number
1
DI Record Publish Date
October 08, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-