Duns Number:790175165
Device Description: The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized 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.This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older 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
1N40C5-1-US-BS
Brand Name
Rapid SARS-CoV-2 Antigen Test Card
Version/Model Number
1N40C5-1-US-BS
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
fad87d12-433c-46aa-a16f-606d478d28f3
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 12, 2022
Package DI Number
00855636003723
Quantity per Package
2
Contains DI Package
00855636003716
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 117 |
U | Unclassified | 2 |