Duns Number:080278407
Device Description: Areta 6 Panel Drug Test Cup (50 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
Catalog Number
ACDOA-264-50
Brand Name
Areta Multi-Drug Test Cup (50 tests kit)
Version/Model Number
ACDOA-264
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
K133968,K133968
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
674f66e0-8e8e-45a2-90ac-231fb9015d18
Public Version Date
July 25, 2022
Public Version Number
7
DI Record Publish Date
July 01, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |