Duns Number:080278407
Device Description: Areta 14-Panel Drug Test Cup (5 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 Areta 14-Panel Drug Test Cup (5 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OPI),OXY,PCP,PPX,TCA,THC
Catalog Number
ACDOA-1144-5
Brand Name
Areta Multi-Drug Test Cup (5 tests kit)
Version/Model Number
ACDOA-1144
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,K133968
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
7bed1e95-7352-4328-9d7c-f89d848c5cb4
Public Version Date
July 25, 2022
Public Version Number
4
DI Record Publish Date
June 29, 2020
Package DI Number
10810038630639
Quantity per Package
16
Contains DI Package
00810038630632
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |