Duns Number:064177324
Device Description: 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/PCP/AMP/BUP
Catalog Number
U-CUP-8124-RCN
Brand Name
UCP Home Drug Screening Test Cups
Version/Model Number
U-CUP-8124-RCN
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130463,K130463,K130463
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
265f5eee-bfcf-4767-ab81-269ffae3ff48
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
August 30, 2016
Package DI Number
20850721007253
Quantity per Package
8
Contains DI Package
10850721007256
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |