Duns Number:065602744
Device Description: Twelve Panel Clear Scan Drug Test Cup Drug Combo: AMP BAR BUP BZO COC MDMA MET Twelve Panel Clear Scan Drug Test Cup Drug Combo: AMP BAR BUP BZO COC MDMA MET MOR MTD OXY PCP THC With Adulterants
Catalog Number
-
Brand Name
Twelve Panel Clear Scan Drug Test Cup With Adulterants
Version/Model Number
CSC-6125AD
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
83b05821-bf51-4bec-9909-2249970a69f2
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
10851000007035
Quantity per Package
4
Contains DI Package
00851000007038
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |