Duns Number:781100966
Device Description: Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1)
Catalog Number
660261
Brand Name
Flowflex COVID-19 Antigen Home Test
Version/Model Number
L031-118B5
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
3a494011-27c7-444b-85a1-a0148ec5c8e5
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 01, 2021
Package DI Number
10682607660268
Quantity per Package
12
Contains DI Package
00682607660261
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |