Duns Number:065602744
Device Description: Six Panel Clear Scan Drug Test Cup with Adulterants Drug Combo AMP/BZO/COC/MET/OPI/THC wit Six Panel Clear Scan Drug Test Cup with Adulterants Drug Combo AMP/BZO/COC/MET/OPI/THC with Adulterants
Catalog Number
-
Brand Name
Six Panel Clear Scan Drug Test Cup with Adulterants
Version/Model Number
CSC-264AD
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
e3a5a906-346f-4448-8089-e349c75242c1
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
November 16, 2017
Package DI Number
00851000007335
Quantity per Package
25
Contains DI Package
00851000007328
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
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 |