Duns Number:781100966
Device Description: Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Catalog Number
200979
Brand Name
ACON SARS-CoV-2 IgG/IgM Rapid Test
Version/Model Number
L031-11711
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QKO
Product Code Name
Reagent, coronavirus serological
Public Device Record Key
6244f1ab-86ac-4a61-ae08-470358c4c934
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 08, 2021
Package DI Number
20682607200973
Quantity per Package
45
Contains DI Package
00682607200979
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |