Duns Number:065602744
Device Description: Thirteen Panel Clear Scan Drug Test Cup Drug Combo: AMP BAR BUP BZO COC MDMA M Thirteen Panel Clear Scan Drug Test Cup Drug Combo: AMP BAR BUP BZO COC MDMA MET MOR MTD OXY PCP TCA THC
Catalog Number
-
Brand Name
Thirteen Panel Clear Scan Drug Test Cup
Version/Model Number
CSC-2135
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
090ff6bd-bdb9-41aa-91fa-f83382b1ab74
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
July 25, 2016
Package DI Number
10850557007994
Quantity per Package
4
Contains DI Package
00850557007997
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 |