Duns Number:806524968
Device Description: DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that want a fast a DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that want a fast and accurate instant drug test which is easy to perform from the privacy of your home to detect marijuana usage.
Catalog Number
-
Brand Name
DrugConfirm™ Single Panel Marijuana Testing Kit
Version/Model Number
03-5601
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
DKE
Product Code Name
Reagents, Test, Tetrahydrocannabinol
Public Device Record Key
2335f629-edcd-4fe8-9309-4d8e94ea46d9
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 06, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |